1. Pink Sheet

Generic Abuse-Deterrent Opioids: Comparison To Brand Will Not Require Use Of Control

 
• By Brenda Sandburg

FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.

Hydrocodone prescription bottle. Hydrocodone is a generic medication name and label was created by photographer.

FDA has heeded the advice of stakeholders and eliminated its recommendation that manufacturers of generic abuse-deterrent opioids compare the brand to a control product for certain studies.

The agency's draft guidance to assist industry in developing generic versions of approved abuse-deterrent formulations (ADFs) advised that for certain comparative studies, such as extractability studies, discriminatory conditions should be...

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