FDA Adds Generic Opioid Abuse-Deterrence to List of Planned 2015 Guidances

The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs.

Adding the planned abuse-deterrence guidance to the list brings to 92 the number of guidances the agency plans to publish this year. The FDA doesn’t give dates for publishing the documents and doesn’t always publish every guidance within the projected timeframe.

The newly added guidance will focus on “General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products.” Combating prescription opioid abuse has been a major priority of the FDA and the Obama administration.

See the full list of 92 guidances here: www.fdanews.com/02-27-15-FDAGuidances.pdf. — Bryan Koenig