Issue Date: April 2, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Abuse-Deterrent Opioids-Evaluation and Labeling
This guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. The guidance makes recommendations about how those studies should be performed and evaluated and discusses how to describe those studies and their implications in product labeling.
Download the Guidance Document
