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FDA Warns Generics Firms About January QbD Deadline for ANDAs

This article was originally published in The Gold Sheet

Executive Summary

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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The generic drug industry is continuing to question the benefits of quality by design, despite its widespread adoption. Generics firms are not seeing an increase in product approvals since making the shift to QbD nor are they seeing much regulatory relief in using this paradigm for making post-approval changes, as deficiency letters continue to focus on traditional ANDA shortcomings and QbD elements are not being observed.

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