Gary Rom

Gary Rom

Faegre Drinker Biddle & Reath LLP

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

12/2/2020  /  Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Labeling , Licenses , Pharmaceutical Industry , Public Comment
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