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May 01 2014

Senators Ask FDA About Guidance Plans for Generic Abuse-Deterrent Formulations of Opioids

Today, Senators Coburn, Enzi, Burr, and Ayotte sent a letter to the FDA, asking the agency about its plans for publication of draft guidance regarding generic abuse-deterrent formulations of opioids. 

It is essential to provide both innovator and generic manufacturers a clear understanding of what standards will be applied to their products as they go through the review process.   Not only has the agency not released any guidance regarding generic products, the agency has yet to finalize its January 2013 draft guidance regarding the approval and labeling of abuse-deterrent opioid drug formulations. Unclear or ineffective communication and guidance would undermine innovative efforts to combat our nation’s opioid abuse epidemic.

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