FDA Releases Draft Guidance for Industry on Abuse-deterrent Generic Opioids
March 25, 2016 at 07:08:00 ET
The U.S. Food and Drug Administration is seeking comments on draft guidance aimed at ensuring that generic opioid drugs are no less abuse-deterrent than brand name products (81 Fed. Reg. 16186). The draft guidance for industry, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, includes recommendations on the studies that should be c... Read More
