U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Generic Drugs and Office of Pharmaceutical Quality

FDA's Public Meeting on Pre-Market Evaluation of Abuse-deterrent Properties of Opioid Drug Products

October 31 - November 1, 2016
Hyattsville, Maryland


Background

The Food and Drug Administration (FDA) is announcing 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the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."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 more generally formulation development and pre-market testing of abuse-deterrent opioid drug products, both innovator and generic.


For More Information

For questions about registration or to request special accommodations due to a disability, contact La'Shaune Morant, The Event Planning Group, at rsvp@tepgevents.com or 240-316-3206.


For general information about the meeting, contact Trang Tran, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, at 240-402-7945.

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