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U.S. Department of Health and Human Services

Drugs

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Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics

The Food and Drug Administration (FDA) is announcing a public meeting to obtain stakeholder input on the design and conduct of the Post Marketing Requirements (PMR) for the Extended Release/Long Acting (ER/LA) opioid drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA is seeking input on these issues from stakeholders, including academia, researchers, patients, state and other federal health officials, health care organizations, health care providers, the pharmaceutical industry, and others from the general public.

 This webpage will be updated as meeting materials are developed.

Date: May 19-20, 2014
Time: 8:00 a.m. to 5:00 p.m. 
Location:FDA White Oak Campus
10903 New Hampshire Avenue,
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993
Information about arrival to FDA's White Oak campus

Registration to Attend the Public Meeting

Individuals who wish to present at the public meeting must register on or before May 9, 2014, at https://erlaopioidpmrmeeting.eventbrite.com.  Individuals who wish to attend the meeting but do not wish to make a presentation should register by May 12, 2014. Written or electronic comments to the docket will be accepted until June 19, 2014.
 

Webcast Information