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FDA Presses Generics Firms to Speed Adoption of QbD, While Questions on Use of Prior Knowledge Persist

This article was originally published in The Gold Sheet

Executive Summary

FDA officials are telling generic drug makers that the agency will be looking for their abbreviated new drug applications to include the type of pharmaceutical development studies and risk assessments that are spelled out in recent guidelines from the International Conference on Harmonization.

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FDA Warns Generics Firms About January QbD Deadline for ANDAs

Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.

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

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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