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Despite Widespread Adoption, Questions Persist on Benefits of QbD

This article was originally published in The Gold Sheet

Executive Summary

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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