Final guidance on evaluation and labeling of abuse-deterrent opioids
[4/1/2015] FDA issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling" explains the FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.
April 1, 2015
- FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
- Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (PDF - 208KB)