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Guidance on Evaluating Generic Opioid Abuse Deterrence

03/25/2016

Federal Register Notice: FDA is making available a draft guidance: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. It recommends studies, including comparative in vitro studies, that should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug. To download this guidance, click here. To view this notice, click here.

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