The document, "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, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.
The draft guidance is part of a larger effort by the FDA to prevent prescription drug abuse and misuse, noted FDA Commissioner Margaret Hamburg, MD.
The FDA is encouraging the development of abuse-deterrent formulations of opioids, and believes that these products have promise to help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.
FDA is seeking public comment on the draft guidance for 60 days and encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies. The FDA will also hold a public meeting to discuss and receive feedback on the draft guidance.
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