jueves, 6 de octubre de 2016

FDA Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products- Drug Information Update

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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

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the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.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.
Individuals seeking to attend the meeting must register by October 17, 2016. Please register for the meeting athttp://www.cvent.com/d/wvq0sm/4Wdisclaimer icon. Space permitting, FDA may accept walk-in registrations the days of the meeting. If you plan to attend the meeting in person and wish to speak at the public meeting, when you register, you must indicate which topic(s) you wish to address:
  • approach to testing FDA recommended in its draft guidance
  • new technologies for deterring abuse of oral opioid drug products, or
  • standardization of in vitro testing methodologies for evaluating purportedly abuse-deterrent formulations of opioid drug products.
For more information, please visit: FDA Public Meeting.