FDA Releases Guidance on Opioids

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FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

In their effort to help industry develop abuse-deterrent opioids, FDA has released Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling, Draft Guidance (CDER, Silver Spring, MD, January 2013). This document gives guidance on studies conducted to demonstrate that a given formulation has abuse-deterrent properties, how FDA will evaluate the studies, and what labeling FDA will approve. The draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan.

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation. This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse,” said FDA Commissioner Margaret A. Hamburg, MD, in a press release.


FDA will accept public comments on the draft guidance for 60 days and FDA “encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies.”  In addition, FDA will hold a public meeting to discuss feedback on the draft guidance.