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Abuse Reduction Claim In Opioid Label Will Be Difficult To Attain

 
• By Cathy Dombrowski

FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.

FDA opened the door Jan. 9 for opioid drug sponsors to make abuse reduction claims for their products, but to get those claims, drug makers must conduct post-marketing epidemiologic studies for which best practices are not yet established.

A draft guidance outlines broadly the kind of data the agency is looking for in an abuse-reduction claim,...

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