1. Pink Sheet

Generic Policy Tweaks In Omnibus Legislation Include Processes Improvements On Late-Stage Label Changes, 505(b)(2) TE Designations

 
• By Nielsen Hobbs

FDA will be able to approve some interchangeable biosimilars more smoothly, but won’t be instructed to provide ANDA sponsors with more information on the inactive ingredients in brand drugs.

Red and Blue Pills
• Source: Shutterstock

The generics industry achieved several policy victories in the Food and Drug Omnibus Reform Act of 2022, and avoided a big defeat – but failed to get a reform that would make it easier to develop ANDAs.

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