Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose

Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention

Opioid analgesics were mainly used for acute and cancer pain. Studies indicating that the treatment of chronic pain other than cancer by doctors has increased the use of opioids.

1987

May MS conchin (morphine sulfate) is approved. For the first time as an opioid analgesic, it was possible to administer every 12 hours instead of every 4 to 6 hours.

1990

August Durajesic (Fentanyl Metermon Acquisition type preparation) is approved. A patch preparation for the first time as an opioid analgesic (sometimes called a skin patch) that is replaced every three days.

1995

In December, it is the first formula of oxycodon to administer 12 hours from 4 to 6 hours every 12 hours. Oxyikontin will eventually become the focus of the Opioid abuse issue and will escalate in the late 2000s.

At the time of the approval, the FDA believed that Oxycontin's release control type preparation would be low because the drug was slowly absorbed and there was no immediate "excitement" or excitement that promoted abuse. FDA is a similar product called MS Conchinen, a MS Conchinen, which has been approved by FDA and has been used in the medical community since 1987, was sold without serious reports of abuse or misuse. It was judged based on.
At the time of the approval of oxyikonchin, FDA's product labels warned that the risk of drug abuse could be overdose of the lethal dose after crushing release control tablets. Ta. At that time, there was no evidence to suggest that oral intake or suck after crushing the release control capsule, which would lead to highly abuse.

1998

November ACTIQ (Fentanyl) was approved. This is the first analgesic approved as a treatment for groundbreaking pain due to cancer, but there is further concerns about safety. ACTIQ was approved after restricting distribution in order to prevent children accidentally taking because they looked like a lollipop and could take them incorrectly, and that there was a possibility of abuse. 。 This drug later becomes a part of the opioid category known as the mucous membrane immediately release type Fentanyl (TIRF) formulation. A mucosa is the fact that the drug is administered through the mucous membrane, such as inside the cheek, under the tongue, or in the nose.

2000-2004

Early 2000s

Reports of overdoses and deaths due to prescription drugs, especially opioids, began to surge, with OxyContin at the center of them. For example, the number of people who admitted to using OxyContin for non-medical purposes skyrocketed from about 400, 000 in 1999 to 1. 9 million in 2002 and 2. 8 million in 2003.

By 2009, the number of emergency department (ED) visits related to medication misuse or abuse was about 1. 2 million, an increase of more than 98% since 2004 and surpassing the number of ED visits related to the use of illicit drugs such as heroin and cocaine. The most prominent of these prescription drug-related deaths and ED visits were opioid pain relievers (OPRs), especially OxyContin.

For more than a decade, the FDA has worked with sponsors to implement risk management programs for many opioid products. However, data has demonstrated that these programs have not adequately managed the risks of misuse, abuse, addiction, and overdose. More action was needed.

2001

January 2001: From 2001 to present, an interagency collaboration is underway to develop public education on prescription drug abuse. Agencies involved include FDA, SAMHSA, the Centers for Substance Abuse Treatment (CSAT), and the National Institute on Drug Abuse (NIDA).

March CSAT hosts a meeting with FDA and other federal agencies, including DEA, NIDA, and the Centers for Disease Control and Prevention (CDC).

July Stronger warnings about potential misuse and abuse are added to OxyContin's label.

To help prescribers select patients who may benefit from OxyContin, the indication for OxyContin is changed from "moderate to severe pain requiring the use of an opioid analgesic for more than a few days" to "control of moderate to severe pain requiring the use of an opioid analgesic for long periods of time."
The label was also changed to state that OxyContin is not appropriate for "as needed" pain or pain immediately following surgery if the pain is mild or not expected to last for a long time.
A "Boxed Warning" was added to reinforce the most important warnings, and information in the "Drug Abuse and Dependence" section was updated. Purdue Pharma, the manufacturer of OxyContin, agreed to implement a Risk Management Program (RMP) to reduce misuse and abuse of OxyContin and issued a letter to health care professionals about the label changes.

2002

January A patient package (PPI) is approved. This is a document written for the patient, describing information about the safe use of pharmaceuticals.

In March, a working group meeting between the Ministry of Agency will be held to discuss Sustainable Opioids, including Oxycontin, and their abuse and diversion. FDA, DEA, NIDA, Samhsa participated.

2003

January FDA issued a warning book (PD F-149KB) for misleading advertisements to Padu Pharma, the manufacturer of Oxyokonchin. In many other details, the warning is that advertising is advertising oxycontin for applications that have eliminated serious safety risks related to oxyconchin, minimizes, and proved safety and efficacy. Specified. Specifically, he pointed out that the advertisement did not clearly present the information described in the "warning section" of the product label for the risk of fatal risk and abuse.

2005-2008

2006

September actic PPI was changed to a medical guide (MG) due to growing consideration of safety. This change was to ensure that each patient who was prescribed the drug would provide sufficient explanation of the serious risk of the same drug. In contrast to the PPI, MG is required to be passed to each patient when entering the prescription.

FENTORA, the second TIRF product, is approved by MG and RMP, but has no sales restrictions.

2007

September FDA announced a public health recommendation on Fentla following reports of adverse events and medications that lead to death.

In September, the Food and Drug Administration Law (FDAAA) was enforced, and the FDA has newly granted a wide range of powers to enhance the safety of pharmaceuticals. One of them is the authority to assume a risk evaluation and easing strategy (REMS) to ensure that pharmaceutical benefits will continue to exceed the risk. REMS aims to obligate the manufacturer to implement a variety of safety measures for specific drugs. This new law was the basis of the future comprehensive REMS program for all the FDA approved (ER) / lon g-term action type (LA) opioid products (see below 2009 to 2012).

September FDA announced that it would ask companies to stop selling unpropered drugs, including the opioid analgesic drug (the active ingredient of opioids sold under the product name of "Baicodin").

2008

Cephalon, the manufacturer of Fentura, demanded that the adaptation to patients with groundbreaking pain other than cancer. The FDA Advisory Committee concluded that the existing RMP of the drug was not valid, and Cephalon was told that a REMS program was needed before considering expanding the adaptation of the drug.

In February, we revised the insertion documents and MGs for Fentra and strengthened the warning.

2009

Feda notified FDA that RMP is inadequate and needs to be replaced with REMS in order to guarantee safe use of Fentora for the treatment of groundbreaking cancer pain, which has already been approved.

March FDA meets an ER/LA opioid analgesic manufacturer and discusses the requirements for the shared system of the class world.

April FDA has partnered with SAMHSA to launch an initiative to secure the use of opioids, Metadon. (Metadon is the most wel l-known treatment for poisoning and dependence on heroin and other drugs, but is also prescribed as a treatment for moderate to severe chronic pain).

In the various public meetings and stakeholders meetings held in May 2009, the FDA held a larg e-scale public meeting on May 27-28, with more than 100 ER/LA opioid preparations. Along with the proposal for the target REMS, he expressed his opinion on opioid preparation. Participating organizations include patient defenders, prescribed organizations, pharmacy groups, insurance, and other government agencies. FDA also recruited opinions through public docks. (See the summary of comments (PD F-6MB).)

July FDA approved the third TIRF (Fentanyl) (Fentanyl) for groundbreaking cancer pain. Onsoris was approved with REMS. At this point, the FDA decided that providing individual REMS on each TIRF product would put a heavy burden on patients, pharmacies, and prescribes, and began discussing a single shared REMS for all TIRF products.

In 2009, FDA notified Cephalon to change Fentora and Actiq RMP to REMS. Cephalon, the manufacturer of Fentura, has demanded expanding adaptation to portraits other than cancer. The FDA Advisory Committee concluded that the existing RMP of the drug was not valid, and Cephalon was told that a REMS program was needed before considering expanding the adaptation of the drug.

In February, we revised the insertion documents and MGs for Fentra and strengthened the warning.

Feda notified FDA that RMP is inadequate and needs to be replaced with REMS in order to guarantee safe use of Fentora for the treatment of groundbreaking cancer pain, which has already been approved.

March FDA meets an ER/LA opioid analgesic manufacturer and discusses the requirements for the shared system of the class world.

2010

In 2009, FDA notified Cephalon to change Fentora and Actiq RMP to REMS. Cephalon, the manufacturer of Fentura, demanded that the adaptation to patients with groundbreaking pain other than cancer. The FDA Advisory Committee concluded that the existing RMP of the drug was not valid, and Cephalon was told that a REMS program was needed before considering expanding the adaptation of the drug.

In February, we revised the insertion documents and MGs for Fentra and strengthened the warning.

Feda notified FDA that RMP is inadequate and needs to be replaced with REMS in order to guarantee safe use of Fentora for the treatment of groundbreaking cancer pain, which has already been approved.

March FDA meets an ER/LA opioid analgesic manufacturer and discusses the requirements for the shared system of the class world.

2011

In 2009, FDA notified Cephalon to change Fentora and Actiq RMP to REMS.

In August, Embeda (Morphine sulfate Narutrexon Sustainable Tablet) was approved. Narutrexon has the function of blocking the action of the opioid. Embeda is the first product that combines opioid analgesics and opioid blockers since Talwin NX (Pentazoshin and Naroxon) approved in 1982. [Suboxon (Buprenolphin and Naroxon), which were approved in 2002, is an opioid blocker, but is not a painful drug but an opioid addiction drug.

In the same way, as in 2007 measures to the Hydrokodon preparation manufacturer that had not been approved in October, the FDA warned each company to discontinue the sales of unpopular codine tablets, which are widely used for pain treatment, to discontinue.

November FDA launched Safe Use Initiative to build and promote publi c-private cooperation in the medical community with the goal of reducing preventive drugs. The safety use of opioids is the main focus of this continuous initiative.

November THE NEW ENGLAND JOURNAL OF MEDICINE In the November 26, FDA Pharmaceutical Research Center (CDER) Dr. Janet Woodcock Medicin e-Pain Management, DRUG SAFETY D THE FDA papers Is posted. In this article, Dr. Woodcoc described the FDA effort to balance the patient's legal analgesics and the management of the risks brought about various painkillers. She cited a recent FDA behavior on commercially available painkillers acetaminophen, lo w-priced opioids, and hig h-priced opioids, such as oxycontin.

December 4 FDA is an industry working group (IWG), which is a representative of 22 pharmaceutical companies who have been asked to cooperate with the development of an effective opioid REMS program for the classwide opioid REMS proposed on December 4th. The stakeholder meeting was held. [IWG will be renamed REMS Program Companies (RPC) in August 2011. ]

Opioids, especially the death and overdose of ER/LA opioids, are due to theft of analgesics from drug boxes and accidental exposure to drugs. Since 2009, FDA has been working with DEA and other organizations to enlighten the general public about the safe disposal of opioids when pain relief is no longer needed.

2012

July FDA holds a joint conference between the anesthetized and lif e-saving drug advisory committee (ALSDAC) and the Pharmaceutical Safety and Risk Management (DSARM) Advisory Committee, and proposes the FDA proposal on the class wide REMS of ER/LA opioid analgesics. (See the AC conference entry on July 22nd to 23, 2010 for the background information discussed at this meeting).

September FDA is a new, abuse, and to promote the development of more secure and effective analgesics, to improve the clinical trials of analgesics (ANALGESIC CLINICAL TRANSLATION, Innovations etworks It has announced a plan to establish a publi c-private partnership that implements multiple scientific projects under the umbrella of Initiative. The Rochester University (UR) was selected as a contract to establish an Active Initiative infrastructure and build a relationship with major experts and organizations in this field.

October FDA held a joint advisory committee (ALSDAC and DSARM) on research to prove the effectiveness of the deterren t-type formulation, and the effectiveness of death, and featured oxycontin and Embada (PD F-149KB )

October FDA has held a meeting with a TIRF sponsor and reported that it is necessary to form a single shared REMS for these products to reduce the burden on the medical system. FDA has promised to cooperate with companies to support the regulation of the program development. Later, regular meetings were held, and each company formed a working group called the Fentanyl REMS REMS industry group (TRIG).

Apart from the REMS program under development in November, in connection with the overall FDA's overall initiatives for the safety use of opioids, the FDA is a voluntary withdrawal of Propok Schiphen, which is sold in the familiar product name Darbon. Recommended. New data shows the possibility that the drug can cause severe toxicity in the heart, even in the dosage.

January: Abstral is approved. This product was approved with MG and REMS wel l-maintained.

April FDA supports Epidemic, the White House's National Narcotics Management Policy Bureau (ONDCP): A response to the American prescription drug crisis (PD F-306KB) is to deal with the national trend for prescription drugs. This is a comprehensive action plan.
June Oxector (oxycodon hydrochloride) approval
Moon: Lazanda approval, fifth TIRF product. This product was approved with MG and REMS wel l-maintained.

September FDA provided a on e-year cooperative agreement to the University of South Carolina to reduce the percentage of opioid misuse, excessive use, and abuse. This will be achieved through the details of the information on prescription opioids and the use of the state prescription drug monitoring program (PDMP) for individual doctors who are larg e-scale obscene prescriptions.

October As part of the thre e-yea r-aged agreement with the Judicial Management Bureau of the Justice, FDA is to support the Prescription Program of the Prescription Program Remarks of Brand Dice University of Brand Dice. Provided funds. This initiative develops a national database of PDMP data in each state, is used for new problems and concerns about specified drugs, and has been implemented to suppress optional misuse, overuse, and abuse. It was investigating the impact of society initiatives.

December FDA has announced the approval of the new agent of Oximolphone hydrochloride (oximolphone hydrochloride), an opioid.

December FDA has approved a single shared REMS system for all TIRF products ("Gore Live" is March 2012). The Industrial Work Subcommittee (see the above) was encouraged to continue working to complete the single shared TIRF REMS system. Regulatory authorities provided the opinions of regulatory authorities throughout the year and continued to consider TRIG's proposal.

December FDA has begun rationalization of the management process of TIRF's single shared REMS.

In January, Subsys (Fentanyl Spray) is approved, and it will be the sixth TIRF product. In the sixth TIRF product, it was directly approved by a single shared Tirf REMS in anticipation of "operation".

January FDA has awarded the Graduate School of Innovation Agency to investigate Maryland University to investigate the use and use of patient prescription agreements in the reduction of the abuse of prescription drugs.

2013

March Single Singl e-shared Tirf REMS has "operated", and FDA has begun collaboration with TRIG to deal with patient access issues.

April FDA holds a scientific workshop to open a public discussion on the potential value of making naloxone available in the community to reduce opioid overdose deaths. Simply put, naloxone, sold under brand names such as Narcan, reverses the effects of opioids.

May FDA and the National Institutes of Health (NIH) Pain Consortium held a meeting on May 30-31 called "Evaluating Analgesic Treatment for Chronic Pain: A Scientific Workshop" to review available data on the effectiveness of analgesics in treating chronic non-cancer pain.

September FDA awards grants of up to three years to three cooperative agreements to explore strategies and interventions that may affect the misuse and abuse of opioid analgesics. The following research topics were funded:

Examine the prescribing habits of physicians who prescribe opioids in excess of 100 mg of morphine equivalent per day and/or who prescribe opioids in combination with benzodiazepines. These prescribers will be targeted with educational and informational emails and PDMP data will be used to examine changes in prescribing habits after education and over time.

To examine the clinical use of various tools that can guide clinicians in prescribing opioids and reduce patients' opioid misuse, overuse, and abuse.

All risk reduction strategies described are currently in use: 1) Screening, Brief Intervention, Referral to Treatment (SBIRT), 2) PDMP, 3) REMS, 4) Payer Initiatives, and 5) Contracting for Care.

In this study, we surveyed approximately 1, 300 prescribers (1, 000 internists, 200 pain specialists, and 100 addiction specialists) to better understand their knowledge, use, and perceived usefulness of these strategies.

To estimate the rate of urine drug testing (UDT) in the first year after chronic opioid therapy (COT) initiation and to identify demographic, clinical, provider, and facility variables associated with UDT use in the U. S. Department of Veterans Affairs (VA) health care system. Qualitative interviews with primary care providers will explore perceptions of barriers to UDT, appropriate care for patients who misuse opioids, and opportunities for therapeutic collaboration with substance abuse specialty care. Describe current clinical practice following abnormal UDT results, including rates of follow-up evaluations and treatment changes among patients starting COT for chronic pain.

2014

In June, with the support of Actition (see September 2010), the Randomized Enrollment Study of Opioid Long-Term Use to Evaluate Efficacy (Resolve) Working Group was established. The formation of this group began based on the plan to develop a protocol of FDA sponsored in NIH (see directly above) and a clinical trial protocol that evaluates the effectiveness of lon g-term use of opioid analgesics. Ta.

July FDA approved the REMS program of the ER/LA opioid class. The program includes a new product labeling of the ER/LA opioid and the maker to develop and provide an opioid training program that can be taken anymore.

August ACTTION established CARES (Consortium for Addition Research on Efficacy and Safety) to tackle issues in clinical trials of poisoning drugs. The Abuse Liability Evaluation for Research, Treatment, And Training (Alertt) project has started under the Action. The project began with the aim of creating a classification scheme and risk evaluation tool used in clinical trials and pos t-marketing adverse event reports, and identifying drug abuse and drug addiction.

October FDA and Actition held a scientific workshop from October 24 to 26, discussing pr e-clinical models and clinical trials to find ways to improve drug discovery and development.

October FDA holds the Drug Safety and Risk Management Advisory Committee (Pharmaceutical Safety Risk Management Advisory Advisory Committee) on October 29-30, and abuse of pharmaceuticals, including hydrocodon as a cough as a combination with analgesics. He was planning to discuss public health benefits and risks, including the potential. The conference was postponed for Hurricane Sandy.

November FDA will hold an ACTTION Alertt Project Working Group on November 28-29, and will discuss consensus recommendations and research research on the definition, scale, and predictive tools.

2015

December FDA held an anesthesia and analgesic advisory committee on December 7, discussing the risk and benefits of applying for new drugs for the first single hydrokodo n-containing hydrochodon tapping capsule. The committee voted against the approval.

January FDA announced on January 9 a guidance document to support the development of opioid drugs with a deterrent effect. This document is entitled Guidance for Industry: Abus e-Deterrent Opioid s-Evaluation and Labeling (PD F-463KB) This document is implemented to prove that a certain format has abuse deterrence. The FDA's current concept is about how the FDA is evaluated by the FDA, and what kind of indicated claims are approved by the FDA.

January FDA holds the Pharmaceutical Safety and Risk Management Advisory Committee (Drug Safety and Risk Management ADVISORY COMMITTEE) (PD F-69KB), and other analgesics for pharmaceuticals containing Hydrocodon. Discussed the public health benefits and risks, including the combination of, or the possibility of abuse as an antitussion. The Ministry of Health and Welfare (HHS) has a scientific and medical evaluation and scheduling of pharmaceuticals, including hydrocodon (or used as ant i-fustotic sputum), from the drug control bureau (DEA). I received a request for a recommendation. Currently, these products are designated as the schedule III of the Regulatory Drug Law (CSA), and DEA is considering r e-scheduling schedule II. The committee has agreed to r e-schedule Hydrokodon products from schedule III regulated substances to schedule II regulatory substances.

February FDA held a public hearing on February 7 and 8, and obtained information (especially scientific evidence such as research data and expert analysis) regarding the use of opioid drugs in chronic pain treatment. 。 Impact of approval drug display in chronic opioid treatment: 15th Hearing

On March 1, FDA and medical professional groups in the public letter to prescribers thoroughly knowledge of the Opioid FDA approval product label to all the types of opioids, and sufficient opioid therapy. I asked for training. The FDA also encouraged all prescriptions to cooperate in controlling the spread of Opioids in Japan.

On April 16, FDA took multiple measures related to oxyikonchin.

On May 10th, FDA decided that the starting of the Oximolphone hydrochloride (oximolphone hydrochloride) sustained lock was not removed from the market due to safety and effectiveness. As a result, the generic drugs of the starting preparation could continue to be approved and sold.

2016

On July 29, FDA held a clinical development program for opioid change; public workshops; recruitment of opinions. The scientific workshop was held to deal with public health concerns related to the labeling of opioid products, including the analgesic optional opiod conversion table.

On September 10, the FDA announced a series of important measures to enhance the safe and appropriate use of the Opioid, a lon g-term and lon g-time (ER/LA) opioid. These measures include changes in the entire class safety label on all ER/LA opioid analgesic and new requirements after commercially available. The FDA also responded to two citizen petitions regarding the opioid labeling.

Final update 2014/7/23

On April 3rd, FDA approved EVZIO (naroxon hydrochloride filter) as an emergency treatment for overdose of opioid intake, known or suspected. Naroxon is a drug that quickly reverses the impact of the opioid overdose. The Ebudio is the first automatic syringe designed to administer Naroxon outside of medical sites.

On April 14, FDA made a final decision to change classwide safety labeling for all sustained release and lon g-term action (ER/LA) opioid analgesics, displaying newborn opioid withdrawal syndrome (NOWS). He responded to two citizen petitions about.

On July 23, the FDA approved TarginiQ ER, a sustained release of Oxycodon and Naroxon. Targinik ER is the second sustainable/lon g-term (ER/LA) opioid analgesic drug with an FDA approval label that describes abuse deterrent characteristics.

On August 19, the FDA approved the revision of the ER/LA opioid analgesic REMS and announced on September 10, 2013 and approved on April 16, 2014 Information on sex display change (SLCS) was incorporated. The most important change was the revision of the approved usage and restrictions, and the warnings, including a slot warning.

On October 17, the FDA requires 24 hours of lon g-term opioid treatment every day, and alternative treatment is inoperable (ER) Opionic analgesic drug, Embeda (ER). A new display of morphine sulfate and nartrexone hydrochloride) was approved. Enbeda is the third ER opioid analgesic that was approved in the display of the abuse deterrent characteristics in accordance with the 2013 guidance proposal, "Abuse Dust-Aid-Evaluation and Display". The new display contains a claim that the Embeda has a characteristic that is expected to reduce oral and nasal abuse during crushing.

November 20, November 20, the FDA requires 24 hours a day, a lon g-term opioid treatment, and is a hicingra ER, an opioid analgesic drug for treating severe severe pain in substitute treatment. (Hydrokodon Talking) was approved. The Hicingra ER is the fourth ER opioid analgesic drug approved in the indication of the abuse deterrent characteristics in accordance with FDA's 2013 guidance proposal "abuse deterrent option-evaluation and display". Hicingra ER has a characteristic that can not completely prevent abuse by chewing, oral administration, crushing, sucking and injection, but is expected to reduce abuse.

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

June 8-9, the FDA's Risk Communication Advisory Committee said, information on the impact on the fetus in the product labeling of metadon or buprinorphin maintenance therapy for opioid poisoning, and the use of these drugs during pregnancy. Discussed information transmission approaches on the benefits and risks of treatment so that medical providers can determine sufficient information. October 17, October 17, FDA is a sustained release (ER) opioid analgesic for treating lon g-term opioid treatment every day, and alternative treatment to treat severe severe pain. A new display of a certain Embeda (morphine sulfate and nartrexone hydrochloride) was approved. Enbeda is the third ER opioid analgesic that was approved in the display of the abuse deterrent characteristics in accordance with the 2013 guidance proposal, "Abuse Dust-Aid-Evaluation and Display". The new display contains a claim that the Embeda has a characteristic that is expected to reduce oral and nasal abuse during crushing.

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

June 8-9, the FDA's Risk Communication Advisory Committee said, information on the impact on the fetus in the product labeling of metadon or buprinorphin maintenance therapy for opioid poisoning, and the use of these drugs during pregnancy. Discussed information transmission approaches on the benefits and risks of treatment so that medical providers can determine sufficient information. On October 17, the FDA requires 24 hours of lon g-term opioid treatment every day, and alternative treatment is inoperable (ER) Opionic analgesic drug, Embeda (ER). A new display of morphine sulfate and nartrexone hydrochloride) was approved. Enbeda is the third ER opioid analgesic that was approved in the display of the abuse deterrent characteristics in accordance with the 2013 guidance proposal, "Abuse Dust-Aid-Evaluation and Display". The new display contains a claim that the Embeda has a characteristic that is expected to reduce oral and nasal abuse during crushing.

2017

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

July 1-2, July 1-2, FDA holds a scientific workshop in collaboration with the National Institute of Democracy, Disease Control Prevention, Drug Hands and Mental Health Service Bureau, and Health Resources Service Bureau. In order to reduce the rate of fatal accidents due to fatal accidents, we have begun a public debate on the issues of taking specific medical sites related to ambulance and opioid prescriptions and taking Naroxon outside of conventional medical sites. The focus of the discussion is that what kind of group is exposed to the risk of optional overdose, and how the public health group can cooperate to use Naroxon to reduce the risk of overdose. It was about legal, regulatory, logistics, and clinical aspects related to being able to do so.

On August 13, the FDA approved Oxycontin (Oxycontin) to pediatric patients who were so serious that the lon g-term opioid treatment for 24 hours every day was needed and inadequate alternative treatment. This approval is an opioi d-resistant pediatric patient who is 11 years or older, has already deducted oxycodon or its valid at least 20 mg or more a day, and is limited to patients with ninja. These patients are expected to continue treatment by opioid for more than a few weeks.

On October 2nd, FDA has an inadequate alternative treatment, MORPHABOND (ER) opioid analgesic (ER) opioid analgesic (ER), which is 24 hours a day, 24 hours a day. Morphine sulfate) was approved. MorPhabond is an indication of the abuse deterrence characteristics in accordance with the industrial guidance published in 2015, "ABUS E-DETERRENT OPIOID S-EVALUATION and Labeling". ER It is an opioid analgesic drug. Morfabond has the characteristics that reduces abuse, but cannot be eliminated when it is crushed and sucked or injected.

November 18, NARCAN nasal cavity, the first FD A-approval spray version of Naroxon hydrochloride, a lifesaving drug that can temporarily suspend or reverse the opioid overdose, including overdose of heroin, is NARCAN nasal cavity. Approved the spray. July 1-2, July 1-2, FDA held a scientific workshop in collaboration with the National Institute of Drug Disaster, Disease Countermeasures Prevention Center, Drug History and Mental Health Service Bureau, and the Health Resources Service Bureau. In order to reduce the rate of fatal accidents due to overdose of opioid, public discussions have been started on specific medical sites related to ambulance and opioid prescriptions and naroxon taking naroxon outside of conventional medical sites. did. The focus of the discussion is that what kind of group is exposed to the risk of optional overdose, and how the public health group can cooperate to use Naroxon to reduce the risk of overdose. It was about legal, regulatory, logistics, and clinical aspects related to being able to do so.

November 18, NARCAN nasal cavity, the first FD A-approval spray version of Naroxon hydrochloride, a lifesaving drug that can temporarily suspend or reverse the opioid overdose, including overdose of heroin, is NARCAN nasal cavity. Approved the spray. July 1-2, July 1-2, FDA holds a scientific workshop in collaboration with the National Institute of Democracy, Disease Control Prevention, Drug Hands and Mental Health Service Bureau, and Health Resources Service Bureau. In order to reduce the rate of fatal accidents, the public debate has begun discussions on specific medical sites related to ambulance and opioid prescriptions and the issues of taking Naroxon outside of conventional medical sites. The focus of the discussion is that what kind of group is exposed to the risk of optional overdose, and how the public health group can cooperate to use Naroxon to reduce the risk of overdose. It was about the legal, regulatory, logistics, and clinical aspects related to being able to do so.

On February 4, the FDA leader called for a wide range of action plans to review the FDA approach to opioid drugs following the spread of opioid abuse. The plan focuses on policies aimed at reversing the spread, while providing effective access to painful patients.

On February 4, FDA canceled the five commercially available (PMR) requirements announced on September 13, 2013, and replaced with 11 PMRs (10 ove r-th e-counter observation research and 1 clinical trials).

FDA is a tw o-day joint at the Pediatrics Advisory Committee (PAC) meeting held on February 19 and April 12, for the PAC, anesthesia and anesthetics, and the pharmaceutical safety and risk management consultation committee. It has been announced that it will present a framework of the current plan about the meeting. This joint meeting is scheduled for September 15 and 16, 2016, and in this meeting, the FDA is actually a proposal to provide proposals on how to deal with the peculiar needs. We plan to call on a wide range of independent experts with experience.

On March 1, the FDA convened a science board, interviewed the following problems related to the current opioid spread, and discussed: (1) the role of the opioid in pain management. (2) FDA's scientific issues facing FDA in the development support of pain treatments, (3) Scientific issues facing FDA to understand the actual usage status of opioids, (4) reduced optional abuse Ove r-th e-counter survey activities on FDA as part of the larger federal, state, and regional correspondence, and (5) opioids on the challenge of providing appropriate pain treatment.

2018

On March 22, the FDA announced that it would require a change in safety labeling in the entire class for immediate release (IR) opioid analgesic drugs. In this change, the FDA demands a new warning for serious risks and abuse that leads to poisoning, overdose, death. FDA also requires some additional safety displays for all prescription opioid products to include additional information on the risk of these drugs. On February 4, the FDA leader called for a wide range of action plans to review the FDA approach to the opiod drug following the spread of opioid abuse. The plan focuses on policies aimed at reversing the spread, while providing effective access to painful patients.

On March 22, the FDA announced that it would require a change in safety labeling in the entire class for immediate release (IR) opioid analgesic drugs. In this change, the FDA demands a new warning for serious risks and abuse that leads to poisoning, overdose, death. FDA also requires some additional safety displays to all prescription opioid products to include additional information on the risk of these drugs. On February 4, the FDA leader called for a wide range of actions to review the FDA approach to the opiod drug following the spread of opioid abuse. The plan focuses on policies aimed at reversing the spread, while providing effective access to painful patients.

On March 24, the FDA announced a guidance proposal entitled "General Principles for Evaluating The Abuse Deterrence of Generic Solid Oral Opioid Drug Products". In this guidance, the FDA evaluates the abuse deterrent of a specific opioidogeneric drug and guarantees that the abuse deterrent of an approved opioid drug with an abuse deterrent (ADF) is not inferior to origin drugs. We recommend the tests that the generic applicant should carry out.

On April 26, the FDA approved the Sustainable Opioid Another Painted Medicine Ecstamza ER (Oxycodon). Ecstamza ER is a drug that treats severe pain that requires 2 4-hour lon g-term opioid treatment every day with insufficient alternative treatment. XTAMPZA ER is the sixt h-ranked Erds that describes the abuse of the FDA's 2015 industries "abaluation and labeling" Opioid analgesic It is a medicine. Ecstamza ER has a characteristic that reduces abuse due to crushing, suction or injection, but cannot be eliminated.

May 3-4, FDA held a joint conference between the Pharmaceutical Safety and Risk Management Advisory Committee and the anesthesia and anesthetics Advisory Committee, and releasing it in a long time, lon g-term action (ER/LA) opioid analgesic medicine. Discussed the results of the risk evaluation and the light reduction strategy (REMS). Each committee minimizes the burden on the medical provision system as much as possible, with REMS (Etasu), which includes elements that guarantee this safety use, without unreasonably burden on the patient's access to drugs. I submitted a comment on whether to do it.

On May 26, FDA will ensure that the medical providers will ensure full information on the benefits and risks of these preparations when pregnant women use Mesadon and Buprenolphin preparation for the drug aid therapy (MAT) for opioid disorder. It has been announced that it will require a change in safety label so that it can be obtained.

On May 26, the FDA approved Probuphine, the first buzzin g-type embedded formulation used for maintenance therapy of opioid o-dependent. Probuphine is an implant designed to supply a constant lo w-level buprinorphin for six months, and is already stable in a buffetenolphin with other forms of lo w-dose to medium doses, and counseling and psychological socially It should be used as part of a complete treatment program, including support.

On August 19, FDA has insufficient alternative treatments, and is a troxyca, an opioid analgesic drug for treating severe pain that requires 24 hours a day, and 24 hours a day. ER (oxycodon hydrochloride and naruto recesson hydrochloride sou r-free capsule) was approved. TROXYCA ER is the seventh ER opioid analgesic drug approved in the display of the abuse deterrent in accordance with the FDA 2015 guidance for the industrial industrial deterrent-evaluation and display. TROXYCA ER has the characteristics that reduces abuse after crushing, oral, suction, or injection, but cannot be eliminated.

August 31, FDA is a class required for pharmaceutical labeling to provide information to medical workers and patients on the serious risk associated with the combination of a specific opioid drug and the benzodiazepine system called benzodiazepine. Announced the overall change. In this change, the FDA is a serious drowsiness, breathing suppression, coma, and death, such as prescription opioid analgesics, opioi d-containing cough drugs, and benzodiazepine drugs, such as extreme drowsiness, respiratory suppression, coma, coma, and death. It requires a box warning and Medication Guide with information on risks.

September 15-16, FDA held joint conference on anesthesia and painful drug advisory committee, pharmaceutical safety and risk management committee, Pediatric Advisory Committee, and the safety of prescription opioid analgesic drugs for pediatric patients. We discussed appropriate development plans to establish the effectiveness, including the use of pharmacokinetics data and the use of outside insertions.

On October 5, the FDA held a joint conference between the anesthesia and analgesic aggressive committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and was intended to be used in the local community, especially in all ages. Discussed the most appropriate naroxon dosage to reverses the effects of overdose of lif e-threatening life, and the role of enabling multiple doses in this situation. The committee also discussed the standards for the prescriber to select the most appropriate doses, and the indications useful for this decision, prior to the event of overdose of opioid. August 19, on August 19, FDA has insufficient alternative treatments and is inoperable (ER) Opioid analgesic drugs to treat severe pain that requires 2 4-hour lon g-term opioid treatment every day. Approved TROXYCA ER (oxycodon hydrochloride and naruto recycle hydrochloride sustained release capsule). TROXYCA ER is the seventh ER opioid analgesic drug approved in the display of the abuse deterrent in accordance with the FDA 2015 guidance for the industrial industrial deterrent-evaluation and display. TROXYCA ER has the characteristics that reduces abuse after crushing, oral, suction, or injection, but cannot be eliminated.

On October 5, the FDA held a joint conference between the anesthesia and analgesic aggressive committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and was intended to be used in the local community, especially in all ages. Discussed the most appropriate naroxon dosage to reverses the effects of overdose of lif e-threatening life, and the role of enabling multiple doses in this situation. The committee also discussed the standards for the prescriber to select the most appropriate doses, and the indications useful for this decision, prior to the event of overdose of opioid. On August 19, FDA has insufficient alternative treatments, and is a troxyca, an opioid analgesic drug for treating severe pain that requires 24 hours a day, and 24 hours a day. ER (oxycodon hydrochloride and naruto recesson hydrochloride sou r-free capsule) was approved. TROXYCA ER is the seventh ER opioid analgesic drug approved in the display of the abuse deterrent in accordance with the FDA 2015 guidance for the industrial industrial deterrent-evaluation and display. TROXYCA ER has the characteristics that reduces abuse after crushing, oral, suction, or injection, but cannot be eliminated.

On October 31-November 1, FDA held an open meeting, "Premarket Evaluation of the Abuse Deterrence of Opioid Drugs," to discuss scientific and technical issues related to the formulation and premarket evaluation of abuse-deterrent opioid drugs. The purpose of the meeting was to provide FDA with an opportunity to discuss the testing approach recommended in the FDA's proposed guidance, "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products," and to solicit public comments from stakeholders. The meeting also provided an opportunity to discuss FDA's efforts to develop standardized in vitro test methods to evaluate the abuse deterrence of opioid drugs. December: On December 16, the FDA approved several safety labeling modifications (SLCs) regarding serious risks for prescription opioid analgesics and opioids approved for medication-assisted treatment (MAT) of opioid addiction. These include a class-wide SLC for immediate-release (IR) opioid analgesics, an SLC for methadone and buprenorphine formulations, and a class-wide SLC regarding serious risks associated with the concomitant use of certain opioid medications with benzodiazepines or other central nervous system (CNS) depressants.

January: On January 9, the FDA approved Arymo ER (morphine sulfate extended-release tablets), an extended-release (ER) opioid analgesic for the treatment of severe pain requiring 24/7 long-term opioid therapy for which alternative treatments are inadequate. Arimo ER is the eighth ER opioid analgesic approved with abuse-deterrent labeling consistent with FDA's 2015 Guidance for Industry, "Abuse-Deterrent Opioids-Evaluation and Labeling." Arimo ER is formulated to impart physicochemical properties that are expected to make it difficult to abuse by injection.

On January 17, the FDA approved Vantrela ER (hydrocodone tartrate extended-release tablets), an extended-release (ER) opioid analgesic, to treat severe pain requiring 24/7 long-term opioid therapy for which alternative treatment options are inadequate. Vantrela ER is the ninth ER opioid analgesic approved with abuse-deterrent labeling consistent with FDA's 2015 Guidance for Industry, "Abuse-Deterrent Opioids - Evaluation and Labeling." The physical and chemical properties of Vantrela ER make abuse difficult via intravenous (injection) routes, and abuse via the nasal and oral routes is expected to be reduced, but not eliminated. However, abuse of Vantrela ER via these routes remains possible.

April On April 20, the FDA announced restrictions on the use of codeine and tramadol in children. These medicines pose serious risks, including slowed or difficult breathing and death, and should not be used in children under 12 years of age because the risks appear to be greater in these children. Use in older children should also be limited. The FDA also recommended that breastfeeding mothers not use codeine and tramadol medicines because of the potential harm to infants.

On April 20, the FDA approved RoxyBond (oxycodone hydrochloride), an opioid pain reliever indicated for the management of pain severe enough to require an opioid pain reliever and for which alternative treatments are inadequate. RoxyBond is the first immediate-release opioid pain reliever approved with a label describing its abuse-deterrent properties consistent with the FDA's 2015 Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling. Laboratory studies have shown that Roxybond tablets are resistant to certain forms of manipulation, such as crushing, grinding and extracting the oxycodone from the tablets, which are commonly used to make opioids easier to abuse through intranasal and intravenous routes. On April 27, the FDA held an expert roundtable of medical professionals to discuss the experience of using cough medicines in children (

May On May 9-10, FDA held a public meeting, "Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics - Exploring the Path Forward," to hear input on issues and challenges related to federal efforts to support training health care providers on pain management and the safe prescribing, dispensing, and patient use of opioids.

On May 10, FDA released the "FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain" (draft blueprint revision), expanding the current blueprint to include information on pain management, including principles of acute and chronic pain management, non-pharmacological treatments for pain, and pharmacological treatments for pain (both non-opioid and opioid analgesics).

June On June 8, the FDA asked Endo Pharmaceuticals to remove the opioid painkiller Opana ER (oxymorphone hydrochloride) from the market, based on concerns that the benefits no longer outweigh the risks.

July On July 6, a JAMA Viewpoint article by Scott Gottlieb, MD, and Janet Woodcock, MD, titled "Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic" was published.

2019

On July 6, at the FDA's request, Endo announced that it would voluntarily remove the reformulated Opana ER from the market.

On July 10-11, FDA held a public meeting, Data and Methods for Assessing the Impact of Opioid Formulations for Abuse Deterrence: A Scientific Discussion of Present and Future Capabilities, to discuss ways to improve the analysis and interpretation of existing data, as well as opportunities and challenges for collecting and/or linking additional data to improve the nation's surveillance and research capabilities in this area.

On July 13, the National Academies of Sciences, Engineering, and Medicine released a consensus report commissioned by FDA outlining the current state of the science on prescription opioid abuse and misuse and the evolving role opioids play in pain management.

On September 11, the FDA held a Pediatric Advisory Committee meeting to discuss the use of prescription opioids containing hydrocodone or codeine to treat cough in pediatric patients. The meeting included reviewing current practices for treating cough in children and the benefits and risks of using prescription opioids in pediatric patients.

On September 20, the FDA recommended that opioid addiction treatment drugs buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). Although the combined use of these drugs increases the risk of serious side effects, the harms of untreated opioid addiction may outweigh these risks. Careful medication management by a medical professional can reduce these risks.

On September 28, FDA sent letters to manufacturers of IR opioid analgesics after determining that a REMS was necessary to ensure that the benefits of these drugs continue to outweigh the risks, informing them that their products intended for outpatient use are subject to the same REMS requirements as ER/LA opioid analgesics.

On November 21, FDA published its final guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The guidance recommends studies, including comparative in vitro and pharmacokinetic studies, that Abbreviated New Drug Application (ANDA) candidates should conduct and submit to FDA in their ANDAs to demonstrate that generic solid oral opioid formulations are non-inferior in terms of abuse deterrence compared to the reference drug across all routes of abuse.

On November 30, the FDA approved Sublocade, the first once-monthly injectable buprenorphine formulation, for the treatment of moderate to severe opioid use disorder in adult patients who have been initiated on a transmucosal (absorbed through mucous membrane) buprenorphine-containing formulation. It is indicated for patients who have been on a stable dose of buprenorphine for at least 7 days.

December On December 11-12, FDA held a public workshop on the role of packaging, storage, and disposal options within a larger effort aimed at addressing abuse, misuse, and inappropriate access to prescription opioid medicines; guiding principles and considerations for the design of opioid packaging, storage, and disposal options; and ways in which FDA can encourage the development and evaluation of opioid packaging, storage, and disposal options that may enhance opioid safety.

January On January 11, FDA Commissioner Scott Gottlieb, MD, announced the 2018 Strategic Policy Roadmap. Part of the roadmap is to reduce the misuse and abuse of opioid medicines.

On January 11, FDA announced that it would require safety labeling changes for prescription cough and cold medicines that contain codeine or hydrocodone to limit use of these medicines to adults 18 years of age or older because the risks of these medicines outweigh the benefits in children under 18 years of age. The FDA is also requiring prescription cough and cold medicines containing codeine or hydrocodone to have additional safety information in the Boxed Warning section of their labels about the risks of misuse, abuse, addiction, overdose, death, and respiratory distress.

On January 24, the FDA and the Federal Trade Commission posted joint warning letters to marketers and distributors of 12 opioid withdrawal treatment products for illegally selling unapproved products that claim to help treat opioid addiction and withdrawal symptoms.

On January 30, the FDA held a public hearing, the Opioid Policy Steering Committee: This hearing was held to hear from stakeholders on how the FDA, under its REMS authority, can reduce the incidence of new addictions, curb overprescribing to limit misuse and abuse of opioid analgesics, and improve the safe use of opioid analgesics.

On January 30, the FDA announced the restrictions on packaging to encourage the safe use of diarrhea protection drug rhuamide (Imodium).

On January 30, the FDA posted the revised blueprint, "Opioid analgesic REMS Educational Blueprint for Health Duriders involved in the treatment and monitoring of painful patients." This blueprint has expanded the current blueprint, including information on acute and chronic pain management, no n-pharmacical treatments for pain, and pain management, including pharmacological treatments for pain. (It is important to note that the revised Blueprint is not considered to be the final edition until the risk assessment and easing strategy of opioid analgesics are approved).

On February 14, FDA held a joint conference between the anesthesia and anesthetics Advisory Committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and required the opioid analgesic submitted by Charleston Laboratories, Inc. For shor t-term management of severe acute pain, we discussed the application for a new drug approval of Hydexor (Product Remember), which contains Hydrokodon, acetaminophen, and pronadin, which prevents and reduces the naughty and vomiting of opioid inducement. 。 Each committee also discussed the possibility of the abuse of this no n-anesthesia painkiller and whether to approve it.

On February 15, Duke Margolis Center is a public workshop that examines the intervening status of medical systems and payers to promote the safe and appropriate prescriptions of opioids through a cooperative agreement with FDA. "Strategy for promoting appropriate prescriptions" was held; discussing how medical systems and payers use data and medical IT tools to support intervention, and approach the medical system. Discuss how it was implemented, its recruitment barriers, and the potential unexpected results of recruitment, and how to build an evidenc e-based construction and success to support the intervention of existing medical systems and payers. Discuss the definition and measurement method.

March 27, the FDA held a psychiatric drug advisory committee, relieving symptoms associated with opioids and promoting the completion of optional cancellation treatments, the US WorldMeds, LLC's new drug approval of Rofexidine hydrochloride submitted by LLC. We discussed the application. On January 30, the FDA announced the restrictions on packaging to promote safe use of diarrhea protection rhuamide (Imodium).

March 27, the FDA held a psychiatric drug advisory committee, relieving symptoms associated with opioids and promoting the completion of optional cancellation treatments, the US WorldMeds, LLC's new drug approval of Rofexidine hydrochloride submitted by LLC. We discussed the application. On January 30, the FDA announced the restrictions on packaging to encourage the safe use of diarrhea protection drug rhuamide (Imodium).

2020

March 27, the FDA held a psychiatristin), and the US WorldMeds, LLC's new drug approval of Rofexidine hydrochloride submitted by US WorldMeds, LLC was adapted to relieve symptoms and promote the completion of opioid cancellation. We discussed the application.

On April 17, FDA will hold a public meeting on patien t-centered pharmaceutical development for opioid disorders (OUD) in collaboration with the United States National Institute of Drug Duscation (NIDA). In addition to NIDA, FDA is closely linked with patient defenders and local organizations to promote the participation of OUD patients. The conference is consistent with the continuous FDA activities aimed at reducing the effects of opioid abuse and poisoning.

On April 20, FDA was a guidance proposal, "Opion o-id addiction: This guidance is the current concept of FDA on pharmaceutical development and test design related to the test of the buzzy findopa preparation (injectable or embedded). It is reflected.

Moon: On May 16th, FDA approved Lucemyra (Rofexidine hydrochloride), the first no n-opioid treatment to alleviate the withdrawal symptoms due to the sudden interruption of the opioid.

On May 22, FDA held a joint conference between the anesthesia and anesthetic agreement and the Pharmaceutical Safety and Risk Management Advisory Committee. , Insys Development Company, Inc. discussed the application for a new drug approval for the buzzy fins submitted. Each committee also discusses whether this product should be approved.

On May 30, the FDA launched an innovation challenge to promote the development of medical devices, including digital health and diagnosis, targeting pain, poisoning, and diversion.

June: On June 1, FDA sent a safety display change notice to a pharmaceutical company with opioid analgesic products approved for outpatient use. Since this notification is generally lacking in REMS recognition among all opioid analgesic prescribes, the "Warning with a frame" and "warning and warning" are the opioid analgesic REMS. It is required to describe new safety information about it.

On June 5, FDA took measures on 53 websites selling unpolished opioids as part of a comprehensive initiative for illegal online sales. On April 17, FDA will hold a public conference on patien t-centered pharmaceuticals for opioid use disorders (OUD) in collaboration with the United States National Institute of Drug Duscation (NIDA). In addition to NIDA, FDA is working closely with patient defenders and local organizations to promote the participation of OUD patients. The conference is consistent with the continuous FDA activities aimed at reducing the effects of opioid abuse and poisoning.

Moon: On May 16th, FDA approved Lucemyra (Rofexidine hydrochloride), the first no n-opioid treatment to alleviate the withdrawal symptoms due to the sudden interruption of the opioid.

2021

On May 30, the FDA launched an innovation challenge to promote the development of medical devices, including digital health and diagnosis, targeting pain, poisoning, and diversion.

On June 5, FDA took measures on 53 websites selling unpolished opioids as part of a comprehensive initiative for illegal online sales. On April 17, FDA will hold a public meeting on patien t-centered pharmaceutical development for opioid disorders (OUD) in collaboration with the United States National Institute of Drug Duscation (NIDA). In addition to NIDA, FDA is working closely with patient defenders and local organizations to promote the participation of OUD patients. The conference consists of continuous FDA activities aimed at reducing the effects of opioid abuse and poisoning.

On April 20, FDA was a guidance proposal, "Opion o-id addiction: This guidance is the current concept of FDA on pharmaceutical development and test design related to the test of the buzzy ficapo preparation (injectable or embedded). It is reflected.

Moon: On May 16th, FDA approved Lucemyra (Rofexidine hydrochloride), the first no n-opioid treatment to alleviate the withdrawal symptoms due to the sudden interruption of the opioid.

On May 22, FDA held a joint conference between the anesthesia and anesthetic agreement and the Pharmaceutical Safety and Risk Management Advisory Committee. , Insys Development Company, Inc. discussed the application for a new drug approval for the buzzy fin spray. Each committee also discusses whether this product should be approved.

On May 30, the FDA launched an innovation challenge to promote the development of medical devices, including digital health and diagnosis, targeting pain, poisoning, and diversion.

June: On June 1st, FDA sent a safety display change notice to a pharmaceutical company with opioid analgesic products approved for outpatient use. Since this notification is generally lacking in REMS recognition among all opioid analgesic prescribes, it is an opioid analgesic REMS in the "Warning with a frame" and "Warning and Caution" of the prescription information. It is required to describe new safety information about it.

On June 5, FDA took measures on 53 websites selling unpolished opioids as part of a comprehensive initiative for illegal online sales.

June On June 26, the FDA held a joint meeting of the Anesthetic and Analgesic Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the New Drug Application submitted by Pain Therapeutics, Inc. for Oxycodone Extended Release Capsules for the management of pain severe enough to require daily, 24-hour, long-term opioid therapy and for which alternative treatments are inadequate. The product is intended to have abuse-deterrent properties due to its physicochemical properties. Each committee will be asked to discuss whether the data submitted by the applicant are sufficient to support a labeling of the product as having abuse-deterrent properties.

June On June 27, the FDA convened internet stakeholders, government agencies, academic researchers, and advocacy groups for a one-day online Opioid Summit to discuss how to collectively take stronger action to combat the opioid crisis by reducing the availability of illicit opioids online.

July: On July 9, FDA held a public meeting on Patient-Centered Drug Development for Chronic Pain to hear patients' perspectives on chronic pain, their views on treatment approaches, and challenges and barriers to accessing treatments for chronic pain.

On August 3, FDA held a joint meeting of the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the results of the evaluation of the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) drugs approved in December 2011. The REMS for TIRF drugs requires that healthcare professionals who prescribe TIRF drugs for outpatient use have special qualifications, that pharmacies that dispense TIRF drugs for inpatient and outpatient use have special qualifications, and that prescriber and patient consent forms be completed before dispensing TIRF drugs for outpatient use. The agency will ask the committee for its evaluation of whether a REMS (ETASU) that includes elements to ensure safe use will ensure safe use, will not unduly burden patients' access to the drug, and will minimize burdens on the healthcare delivery system to the extent possible. The agency will also ask the committee for its opinion on possible modifications to the goals and requirements of the TIRF REMS, and will also ask for its opinion on the appropriateness of the evaluation in the REMS evaluation to determine whether the goals of the TIRF REMS have been achieved. On August 6, the FDA released a proposed guidance for industry, "Opioid Use Disorder": The guidance is intended to assist sponsors in developing drugs for the pharmacotherapy of opioid use disorder (OUD) and addresses acceptable clinical endpoints to demonstrate the efficacy of such drugs.

2022

On August 22, the FDA contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to facilitate the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

On August 28, the FDA took action against 21 websites selling unapproved opioids as part of its efforts to target illegal online sales.

September: On September 7, the FDA approved new dosages of buprenorphine and naloxone sublingual film for maintenance treatment of opioid dependence.

On September 18, the FDA approved an opioid analgesic REMS.

On September 20, a cooperative agreement with the FDA held a public workshop "Expanding access to effective treatment for opioid usage disorders": Barriers of cavity based on evidence. Provider's perspective to reduce

On September 27-28, the FDA Women's Health Bureau held a two-day public conference "Opioid and Nicotine Use, Dependence, and Recovery" in collaboration with CDER and CTP.

On October 11, FDA holds an anesthesia and analgesic advisory committee, and is an Oriceridine 1 milligram / millilitle submitted by TREVENA as an adaptation of moderate to severe acute pain in adult patients who need opioids. Discussed the application for a new drug approval 210730. The committee also discussed the examination of validity and safety data and benefits and risks.

On October 12, FDA holds an anesthesia and anesthetic advisory committee, and is submitted by Acelrx Pharmaceuticals, Inc., which is so severe that it requires opioid analgesic and is inadequate alternative treatment. New drug approval application for pain management 209128 (sufentanil locked tablet) was discussed on adult patients in a medica l-managed environment. The committee also discussed risk benefits and whether to approve the product.

On November 1, FDA holds a joint conference between the Psychiatric Pharmaceutical Advisory Committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and adapts the combination of depression disorders submitted by Alks. Discussion, safety, and risk benefit profiles were discussed about the new drug approval application for the middle fan under the tablet 210417.

On November 2, the FDA approved for the first time to use oral Swentanil analgesics under medical surveillance. On September 20, a cooperative agreement with the FDA held the Duke University Margolis Health Policy Center "Expanding Effective Treatment of Opioid Disorders": Care based on evidence. Provider's perspective to reduce barriers to

On September 27-28, the FDA Women's Health Bureau held a two-day public conference "Opioid and Nicotine Use, Dependence, and Recovery" in collaboration with CDER and CTP.

On November 2, the FDA approved for the first time to use oral Swentanil analgesics under medical surveillance. On September 20, a cooperative agreement with the FDA held a public workshop "Expanding access to effective treatment for opioid usage disorders": Barriers of cavity based on evidence. Provider's perspective to reduce

On September 27-28, the FDA Women's Health Bureau held a two-day public conference "Opioid and Nicotine Use, Dependence, and Recovery" in collaboration with CDER and CTP.

On November 2, the FDA approved for the first time to use oral Swentanil analgesics under medical surveillance.

On November 14, FDA held a joint conference between the anesthesia and aggressive drug advisory committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and inadequate, inadequate alternative treatment that requires opioid analgesic. A new drug approval application for an oxycodon's immediate release oral tablet preparation that resisted the general physical and chemical operations submitted by SPECGX Inc. for the management of Discussed 209774. The committee also proved that the abuse deterioration of the product proposed by the applicant was sufficient to describe this information on the product label, and whether the product should be approved. I decided.

2023

On November 15, the FDA held an anesthesia and analgesic aggressive committee, discussing the evaluation of opioid analgesics in clinical trials of acute pain. The committee also commented on the test design and endpoints of these examinations, and how to judge clinical validity of the results.

January: On January 17, FDA announced the results of unprecedented work for the design, testing, and verification of the main display requirements necessary for the approval of Naroxon's general drug (OTC). As a whole, the study demonstrated that the model DFL is well understood by consumers and is allowed to use the manufacturer to support the OTC Naroxon development program.

February 6, FDA, FDA is the final guidance "Opioid usage disorder: This guidance is now the current Pharmaceutical Development and Test Design for Pharmaceutical Development and Examination Design. It reflects the way of thinking.

On February 12, the FDA announced a continuous initiatives to prevent illegal optional spreads, secure US pharmaceutical supply chains, and to confront the spread of opioids.

On March 19, the FDA took measures for unpolished products that claimed to treat poisoning, chronic pain, and other severe symptoms.

On March 27, FDA announced a new measure to strengthen FDA's safety requirements, aimed at reducing the risk related to the transconnected Fentanyl preparation. FDA held a joint conference between the anesthesia and aggressive aggressive committee and the Pharmaceutical Safety and Risk Management Advisory Committee on November 14, and was so serious that it needed opioid analgesics. A new drug on the immediate release oral tablet preparation of Oxycodon's instantaneous release tablets, which intends to control the general physical and chemical operations for sufficient pain management and to suppress intravenous and nasal abuse. Approval application 209774 was discussed. The committee also proved that the abuse deterioration of the product proposed by the applicant was sufficient to describe this information on the product label, and whether the product should be approved. I decided.

January: On January 17, FDA announced the results of unprecedented work for the design, testing, and verification of the main display requirements necessary for the approval of Naroxon's general drug (OTC). As a whole, this study demonstrated that the model DFL is well understood by consumers and is allowed to use the manufacturer to support the OTC Naroxon development program.

On February 12, the FDA announced a continuous initiatives to prevent illegal optional spreads, secure US pharmaceutical supply chains, and to confront the spread of opioids.

On March 19, the FDA took measures for unpolished products that claimed to treat poisoning, chronic pain, and other severe symptoms.

On March 27, FDA announced a new measure to strengthen FDA's safety requirements, aimed at reducing the risk related to the transconnected Fentanyl preparation. On November 14, FDA held a joint conference between the anesthesia and aggressive drug advisory committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and inadequate, inadequate alternative treatment that requires opioid analgesic. A new drug approval application for an oxycodon's immediate release oral tablet preparation that resisted the general physical and chemical operations submitted by SPECGX Inc. for the management of Discussed 209774. The committee also proved that the abuse deterioration of the product proposed by the applicant was sufficient to describe this information on the product label, and whether the product should be approved. I decided.

On February 12, the FDA announced a continuous initiatives to prevent illegal optional spreads, secure US pharmaceutical supply chains, and to confront the spread of opioids.

On March 19, the FDA took measures for unpolished products that claimed to treat poisoning, chronic pain, and other severe symptoms.

On March 27, FDA announced a new measure to strengthen FDA's safety requirements, aimed at reducing the risk related to the transconnected Fentanyl preparation.

April On April 2, the FDA took new enforcement action as part of its continuing efforts to eradicate illegal online sales of opioids.

On April 2, the FDA hosted internet stakeholders, opinion leaders, government agencies, academic researchers, and advocacy groups at its second Online Opioid Summit.

On April 9, the FDA announced reports of harm from abruptly stopping opioid painkillers and called for labeling changes to instruct prescribers on gradual, individualized tapering.

On April 19, the FDA approved the first generic naloxone nasal spray to treat opioid overdoses.

On April 25, the FDA launched a public education campaign encouraging people to safely remove unused opioid painkillers from their homes.

May On May 30, FDA opened a public docket requesting information on requiring metered-dose blister packaging of certain opioid analgesics to reduce unnecessary exposure to opioids.

June On June 11-12, FDA held a joint meeting of its Drug Safety and Risk Management Advisory Committee and its Anesthesia and Analgesia Advisory Committee to solicit input on the clinical benefits and safety associated with the higher dose ranges of opioid analgesics (both high-strength preparations and high daily doses) in outpatient settings. FDA is interested in better understanding current clinical use, circumstances in which the use of higher doses of opioid analgesics may be justified, the magnitude and frequency of harms associated with higher doses of opioid analgesics versus lower doses, and optimal strategies to manage these risks while ensuring patients have access to adequate pain management.

On June 20, FDA released a draft guidance, "Opioid Analgesics": The guidance describes the application of the benefit-risk assessment framework that FDA uses in evaluating applications for opioid analgesics and summarizes information that opioid analgesic applicants can provide to assist FDA in its benefit-risk assessment.

On July 2, FDA warned repackagers distributing drug substances containing opioids for endangering consumers through serious violations of manufacturing quality standards.

September: On September 17, the FDA held a public hearing, "Future Opioid Analgesic Approval Criteria and Incentives for New Therapeutics for the Treatment of Pain and Addiction," to hear from stakeholders about how the FDA can best consider existing therapies, among other factors, in the approval process for new opioids and in reviewing applications for new opioids for the treatment of pain.

On September 20, the FDA issued a statement saying it continues to work to increase the availability of all forms of naloxone to reduce opioid overdose deaths.

On September 20, the FDA announced it had approved new packaging for the original generic version of loperamide to curb abuse and misuse.

On September 26, FDA held a joint meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees to discuss the pediatric-focused safety review of OxyContin (oxycodone hydrochloride) extended-release tablets required by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss considerations for opioid analgesic labeling and pediatric data from Pediatric Research Equity Act studies on opioids in general, using Opana IR as an example.

On September 30, 2019, FDA and DEA warned website operators illegally selling opioids.

On October 24, FDA outlined its performance in the first year of implementing SUPPORT Act authorities to address the opioid crisis.

November On November 26, the FDA issues a warning letter for products illegally marketed as treatments for health conditions, including opioid withdrawal.

2024

December On December 11, the FDA issues a warning letter for failing to state the most serious risks in advertising for a medication-assisted treatment.

On December 19, the National Academies of Sciences, Engineering, and Medicine release a consensus report commissioned by the FDA on the development of opioid prescribing guidelines for acute pain.

January FDA held a joint conference between the anesthesia and anesthetics advisory committee and the Pharmaceutical Safety and Risk Management Advisory Committee on January 14, and provided 2 4-hour, lon g-term opioid treatment submitted by Nektar Therapeutics. A new drug approval of Oxicodegool, a complete MU-opioid receptor, which has severe pain as needed and has insufficient alternative treatment and is indicated by the management of chronic low back pain in adult patients. We discussed the application (NDA). Each committee was urged to discuss data on safety and effectiveness, as well as the entire risk, benefit profile of the product.

On January 15, the FDA held a joint conference between the anesthesia and analgesic advisory committee and the Pharmaceutical Safety and Risk Management Advisory Committee. In the morning session, the opioids submitted by Esteve Pharmacyuticals and Tramador 44 milligrams and 56 milligrams of Selecoxib, which are a combination of no n-steroidal ant i-inflammatory drugs, are serious and replaced by the need for opioid analgesic. An application for a new drug approval on the management of acute pain in adults with insufficient treatment was deliberated. Each committee was urged to discuss data on safety and effectiveness, as well as the entire risk, benefit profile of the product.

In the afternoon session, the NDA, an Oxycodon, an oral tablet submitted by Intellipharmaceutics Corp.. The product is prescribed to deter abuse, and the applicant has submitted data that supports the abuse deterrent character of this product. Each committee was asked to discuss whether the applicant demonstrated the abuse deterrence effect and the overall picture of this drug.

On June 8, FDA and National Telecommunications and Information ADMINISTRATION (NTIA) will start a 12 0-day test operation to reduce the possibility of obtaining unproparded options sold illegally online. January FDA held a joint conference between the anesthesia and anesthetics advisory committee and the Pharmaceutical Advisory Committee on January 14, and submitted by NEKTAR THERAPEUTICS, 24 hours a day, lon g-term. Oxycodegor, a complete MU-opioid receptor who has severe pain enough to require opioid treatment and is indicated by the management of chronic low back pain in adult patients whose alternative treatment is inadequate. Discussed the application for a new drug approval (NDA). Each committee was urged to discuss data on safety and effectiveness, as well as the entire risk, benefit profile of the product.

On June 8, FDA and National Telecommunications and INFORMATION (NTIA) will start a 12 0-day test operation to reduce the possibility of acquisition of unpredictable options sold illegally online. January FDA held a joint conference between the anesthesia and anesthetics advisory committee and the Pharmaceutical Safety and Risk Management Advisory Committee on January 14, and provided 2 4-hour, lon g-term opioid treatment submitted by Nektar Therapeutics. A new drug approval of Oxicodegool, a complete MU-opioid receptor, which has severe pain as needed and has insufficient alternative treatment and is indicated by the management of chronic low back pain in adult patients. We discussed the application (NDA). Each committee was urged to discuss data on safety and effectiveness, as well as the entire risk, benefit profile of the product.

In the afternoon session, the NDA, an Oxycodon, an oral tablet submitted by Intellipharmaceutics Corp.. The product is prescribed to deter abuse, and the applicant has submitted data that supports the abuse deterioration characteristics of this product. Each committee was asked to discuss whether the applicant demonstrated the abuse deterrence effect and the overall picture of this drug.

July 23: On July 23, FDA announced the Drug Safety Communication, and medical workers have opioid analgesic or OUD treatment for all opioid analgesics and OUD therapy drug manufacturers. When prescribing or updating, we discussed the possibility of obtaining the naroxon, and called for the prescription information a new recommendation for the prescription to evaluate the necessity of the naroxon prescription for each patient. In addition, he advised medical experts to consider prescribing naroxon to patients who are increasingly risk of overdose of opioid, regardless of whether they are prescribed for opioid analgesics and OUD drugs. Such patients include people who have been diagnosed with OUD in the past or in the past, or have experienced opioid intake in the past.

Summary Timeline

August: On August 7, the FDA was painful as the opioid active drug (general name: Oriseridine) was so painful that the opioid was irregular and the alternative treatment was insufficient. Approved to use it for pain management.

On August 6, the FDA approved NARCAN (Naroxon Hydrochloride) Shabetto Spray from the current two years to three years, and approved a pr e-approval application to update the label.

On September 1, FDA signed a cooperation agreement to support the development of clinical practice guidelines based on evidence on acute toothachhor's management.

On September 10-11, FDA held a joint conference between the Pharmaceutical Safety and Risk Management Advisory Committee and the anesthesia and Anesthetics Advisory Committee, and Oxycontin (OxyContin Sugetsu Lock, Purdue Pharma L. P.) Requirements to evaluate the effects of the recovery agent, discussed the results of post-marketing surveys (over-the-counter postpartum requirements 3051-1, 3051-2, 3051-3, 3051-4), NDA 022272). It is a test that evaluates the impact on no n-lethal overdose administration. The committee has discussed whether these researches have proved a significant reduction in these results, along with other information from the published literature. The committee also discussed the extensive impact on public health by the reconnection of OxyContin. July 23, FDA announced the Drug Safety Communication, and the medical professional is an opioid analgesic or OUD for all opioid analgesics and OUD therapy drug manufacturers. When prescribing or renewing treatments, we will discuss the possibility of obtaining naroxon and to ensure that each patient to evaluate the necessity of the naroxon prescription, so that new recommendations related to Naroxon will be added to the prescription information. Ta. In addition, he advised medical experts to consider prescribing naroxon to patients who are increasingly risk of overdose of opioid, regardless of whether they are prescribed for opioid analgesics and OUD drugs. Such patients include people who have been diagnosed with OUD in the past or in the past, or have experienced opioid intake in the past.

On August 6, the FDA approved NARCAN (Naroxon Hydrochloride) Shabetto Spray from the current two years to three years, and approved a pr e-approval application to update the label.

On September 1, FDA signed a cooperation agreement to support the development of clinical practice guidelines based on evidence on acute toothachhor's management.

On September 10-11, FDA held a joint conference between the Pharmaceutical Safety and Risk Management Advisory Committee and the anesthesia and Anesthetics Advisory Committee, and Oxycontin (OxyContin Sugetsu Lock, Purdue Pharma L. P.) Requirements to evaluate the effects of the recovery agent, discussed the results of post-marketing surveys (over-the-counter postpartum requirements 3051-1, 3051-2, 3051-3, 3051-4), NDA 022272). It is a test that evaluates the impact on no n-lethal overdose administration. The committee has discussed whether these researches have proved a significant reduction in these results, along with other information from the published literature. The committee also discussed the extensive impact on public health by the reconnection of OxyContin. July 23: On July 23, FDA announced the Drug Safety Communication, and medical workers have opioid analgesic or OUD treatment for all opioid analgesics and OUD therapy drug manufacturers. When prescribing or updating, we discussed the possibility of obtaining the naroxon, and called for the prescription information a new recommendation for the prescription to evaluate the necessity of the naroxon prescription for each patient. In addition, he advised medical experts to consider prescribing naroxon to patients who are increasingly risk of overdose of opioid, regardless of whether they are prescribed for opioid analgesics and OUD drugs. Such patients include those who have been diagnosed with OUD in the past or in the past, and those who have experienced overdose of opioids in the past.

On August 6, the FDA approved NARCAN (Naroxon Hydrochloride) Shabetto Spray from the current two years to three years, and approved a pr e-approval application to update the label.

On September 1, FDA signed a cooperation agreement to support the development of clinical practice guidelines based on evidence on acute toothachhor's management.

On October 2, the FDA announced the final guidance for the industry, "Opioid Usage Disorder": This guidance aims to help sponsors develop an opioid disorder (OUD) therapeutic drug. This guidance describes clinical endpoints that are acceptable to prove the effectiveness of opioid disorder (OUD) treatments.

November Hydrokodon, acetaminophen, and hydexor's new drug approval application include shor t-term pos t-operative shor t-term management (exceeding 3 days), and nausea and vomiting. Aiming on a new drug approval application submitted by õlas Pharma for the preventive and vomiting of the opioid inducement in patients with risks or vomiting or vomiting.

On December 23, FDA finalized the risk evaluation and light reduction strategy (REMS) of the mucous membrane instantly released Fentanyl (TIRF), cope with the continuation of prescription practices that are concerned, and monitor adverse events. Improve abilities and ensure safe use of these drugs.

On February 1, FDA is about the Pilot Program with the US Telecommunications Information Bureau (NTIA) and the three domain name registrys to reduce the possibility of obtaining unapproved opioids illegally sold online. Provided the latest information.

On February 16, FDA issued a warning to Acelrx Pharmaceuticals, Inc. for promoting a powerful option of DSUVIA, a powerful opioid analgesic drug, DSUVIA.

On March 1, FDA, the abuse deterrent preparation (ADF), that is, chewing, taking oral taking, shattering, sucking and injection, it is expected that the abuse cannot be completely prevented, but it will be reduced. The first generic opioid, Hydrokodon Wallic acid, has been approved as a formula with the characteristics of the FDA.

On March 24, FDA announced the white paper "Introduction to FDA'S's Opioid Systems Model" (introduction of the FDA opioid system model). This white paper introduces the efforts of FDA's opioid system models, discusses the potential use of the model, shows the scope of the model and the structure, and emphasizes the potential proportional areas of policy analysis. However, he has an overview of the current work.

On April 15, the FDA held a public workshop "Morphine MillIGRAM Equivalents": This workshop deepened the understanding of science and data, which is the basis of MME calculation of opioid analgesics, and gaps in these data. To discuss the scientific evidence of morphine milligram (MME) by gathering stakeholders with the aim of discussing the future direction of improving and improving the scientific evidence of MME. It is.

On April 29, the FDA approved that the opioid analgesic pharmaceutical drug molphine injections were used to manage the insufficient treatment of alternative treatment.

On April 30, the FDA approved a higher dose as a treatment for overdose of opioido, a higher dose for naroxon spray.

On June 2, FDA approved that the opioid analgesic drugs, i n-sulfine, and morphine tablets, were used to manage severe adults in poor adults and child patients.

On July 12-13, the Duk e-Margolis Center held a public workshop "Safety use of benzodiazepine" in a cooperative agreement with FDA: regulators, academic researchers, clinicians, and, in this workshop. Patients and other stakeholders met together to discuss epidemiological data and data on abuse liability, patients and clinicians' perspectives and experiences, and gaps on data and understanding of the safety use of benzodiazepine.

October FDA and Actition held a scientific workshop from October 24 to 26, discussing pr e-clinical models and clinical trials to find ways to improve drug discovery and development.

November FDA will hold an ACTTION Alertt Project Working Group on November 28-29, and will discuss consensus recommendations and research research on the definition, scale, and predictive tools.

October 18, the Reagan-Yudor Foundation, "A Practical Research Agenda for Treatment Development for" through a cooperative agreement with FDA Imulant USE "DISORDER)" was held to discuss practical research topics focusing on clinical trial design and en d-point candidate innovation to evaluate potential treatment for stimulant use disorder.

On January 12, the FDA announced the Drug Safety Communication, warning that dental problems related to oral dissolution, including Buprenolphin, have been reported. Dental issues include tooth decay, oral infections, dental loss, etc., and have been reported in patients who have no history of dental problems. The bureau called for a new warning on the prescription information and patient's drug guide to all the brewing guides that dissolve in the oral cavity a new warning on the risk of dental problems.

On April 16, FDA took multiple measures related to oxyikonchin.

On February 28, the FDA approved the adaptation of military and chemical accidents for naroxon hydrochloride for opioid overdose treatment.

On March 29, a cooperative agreement with FDA held the Reagan Yudor Foundation "Naloxone Access": Investigating frequently asked questions on how to get Naroxon, a drug that restores opioid overdose. did.

Final update 2014/7/23

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

November On November 15, FDA issued a Federal Register notice to alert application holders for certain prescription naloxone formulations of FDA's preliminary evaluation and the possibility that FDA may ultimately determine that the formulations are safe and effective for use without a prescription through approval of a nonprescription naloxone formulation.

November On November 28, FDA held a conference call with stakeholders to discuss access to naloxone and to affirm FDA's commitment to support harm reduction organizations' efforts to obtain FDA-approved naloxone products.

On January 30, the FDA approved the improved type of Zohidoro ER (Hydrokodon Talking Capsule). The FDA does not approve the indication of the abuse deterrence of Zhhidro ER.

On April 1, FDA announced a final guidance to support the development of opioid drugs that could have a deterrent effect.

November 18, NARCAN nasal cavity, the first FD A-approval spray version of Naroxon hydrochloride, a lifesaving drug that can temporarily suspend or reverse the opioid overdose, including overdose of heroin, is NARCAN nasal cavity. Approved the spray. July 1-2, July 1-2, FDA holds a scientific workshop in collaboration with the National Institute of Democracy, Disease Control Prevention, Drug Hands and Mental Health Service Bureau, and Health Resources Service Bureau. In order to reduce the rate of fatal accidents, the public debate has begun discussions on specific medical sites related to ambulance and opioid prescriptions and the issues of taking Naroxon outside of conventional medical sites. The focus of the discussion is that what kind of group is exposed to the risk of optional overdose, and how the public health group can cooperate to use Naroxon to reduce the risk of overdose. It was about the legal, regulatory, logistics, and clinical aspects related to being able to do so.

May On May 22, the FDA approved nalmefene nasal spray to treat opioid overdose.

On March 22, the FDA announced that it would require a change in safety labeling in the entire class for immediate release (IR) opioid analgesic drugs. In this change, the FDA demands a new warning for serious risks and abuse that leads to poisoning, overdose, death. FDA also requires some additional safety displays to all prescription opioid products to include additional information on the risk of these drugs. On February 4, the FDA leader called for a wide range of actions to review the FDA approach to the opiod drug following the spread of opioid abuse. The plan focuses on policies aimed at reversing the spread, while providing effective access to painful patients.

On July 6, the FDA approved the first generic application for Narutrexon Sustainable Ingeneration Suspension, which indicates the treatment of alcohol and opioid disorders.

On July 18, the FDA approved the first commercially available nason nasal drug for treatment of opioid overdose.

On October 5, the FDA held a joint conference between the anesthesia and analgesic aggressive committee and the Pharmaceutical Safety and Risk Management Advisory Committee, and was intended to be used in the local community, especially in all ages. Discussed the most appropriate naroxon dosage to reverses the effects of overdose of lif e-threatening life, and the role of enabling multiple doses in this situation. The committee also discussed the standards for the prescriber to select the most appropriate doses, and the indications useful for this decision, prior to the event of overdose of opioid. On August 19, FDA has insufficient alternative treatments, and is a troxyca, an opioid analgesic drug for treating severe pain that requires 24 hours a day, and 24 hours a day. ER (oxycodon hydrochloride and naruto recesson hydrochloride sou r-free capsule) was approved. TROXYCA ER is the seventh ER opioid analgesic drug approved in the display of the abuse deterrent in accordance with the FDA 2015 guidance for the industrial industrial deterrent-evaluation and display. TROXYCA ER has the characteristics that reduces abuse after crushing, oral, suction, or injection, but cannot be eliminated.

July On July 6, a JAMA Viewpoint article by Scott Gottlieb, MD, and Janet Woodcock, MD, titled "Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic" was published.

On July 6, at the FDA's request, Endo announced that it would voluntarily remove the reformulated Opana ER from the market.

January On January 11, FDA Commissioner Scott Gottlieb, MD, announced the 2018 Strategic Policy Roadmap. Part of the roadmap is to reduce the misuse and abuse of opioid medicines.

On January 30, the FDA announced the restrictions on packaging to encourage the safe use of diarrhea protection drug rhuamide (Imodium).

March 27, the FDA held a psychiatric drug advisory committee, relieving symptoms associated with opioids and promoting the completion of optional cancellation treatments, the US WorldMeds, LLC's new drug approval of Rofexidine hydrochloride submitted by LLC. We discussed the application. On January 30, the FDA announced the restrictions on packaging to encourage the safe use of diarrhea protection drug rhuamide (Imodium).

The FDA holds the Drug Safety and Risk Management Advisory Comittee (PD F-69KB) (PD F-69KB) on January 24-25, and the public health and risk of drugs containing hydrocodon. Discussed (including the possibility).

On March 1, the FDA and the medical group will thoroughly know the Opioid FDA approval product label to all the holders of the opioids in the open letter to the prescribed person and receive sufficient training on opioid treatment. I asked for it. The FDA also encouraged all prescriptions to cooperate in controlling the spread of Opioids in Japan.