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US FDA Adds Capacity For Bioequivalence Studies That Could Help Build Trust In Generics

 
• By Bowman Cox

Agency will fund clinical studies to answer complaints of generic inequivalence and resolve scientific controversies over methods used to support approval.

Clinical trial
This shoud still work just fine • Source: Shutterstock

The US Food and Drug Administration is putting itself in a better position to check whether, and under what conditions, generic drugs it has approved remain bioequivalent to their brand counterparts by contracting for more capability to run its own clinical bioequivalence trials.

Such studies could help build trust among providers and patients in the quality of generic drug products, while also building...

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