Drugs

Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products

The FDA is holding a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The meeting will also provide an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. FDA is seeking input from all stakeholders, including patients, health care providers, health care payers, the pharmaceutical industry, patient advocates, academics, researchers, and other government entities.

Advance registration for the meeting closed October 26, 2016. Space permitting, in-person registration is available at the meeting location on the days of the meeting, October 31 and November 1, 2016. Online registration for the webcast is also available on those dates, capacity permitting. Please use this link for webcast registration: http://www.cvent.com/d/wvq0sm/disclaimer icon

In order to permit the widest possible opportunity for public comment, FDA has also opened a docket. Electronic or written comments regarding scientific and technical issues relating to formulation development and pre-market evaluation of abuse-deterrent properties of opioid drug products may be submitted to docket number FDA-2016-N-2896. The deadline for submitting comments is January 3, 2017.

Dates and Times:

  • October 31, 2016 – 8:30 a.m. to 4:30 p.m.
  • November 1, 2016 – 8:30 a.m. to 4:00 p.m.

Note: The meeting may be extended or end early depending on the level of public participation.

Location:

College Park Marriott Hotel and Conference Center
3501 University Blvd. East
Hyattsville, MD 20783

Webcast Information:

Transcripts

The transcripts of the public workshop are available below:

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Presentations: Day 1

Page Last Updated: 12/21/2017
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