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FDA Mulls Requiring QbD as Some Generics Firms and Others Resist It

This article was originally published in The Gold Sheet

Executive Summary

Quality by Design could become mandatory in the U.S. as FDA seeks ways to motivate the last holdouts from the new drug quality paradigm. Some generics firms want FDA to make them do it so competitors won't take first-to-file short cuts. FDA also looks to develop guidance that provides greater detail on how to use QbD. The agency also is working to help old-school reviewers with empirical mindsets to embrace new science-based QbD approaches.

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