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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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Despite Widespread Adoption, Questions Persist on Benefits of QbD

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.

FDA Proposes QbR for New Drugs to Level the Playing Field for CMC Reviews

FDA has proposed to expand the use of question-based review, or QbR, to new drugs as part of its efforts to harmonize new and generic drug chemistry reviews. This reflects the agency’s latest efforts to improve the quality of brand and generic drugs by levying “equal expectations” for both.

Generic Industry Has Made Progress Implementing QbD

The generic drug industry has progressed swiftly with QbD, reports an FDA OGD official. The share of ANDAs containing QbD elements has tripled from 25% in June 2012 to 83% in January 2013 – while brands struggled to reach 14% QbD last year with their NDA filings.

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