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Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

Aug 16th, 2014

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The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies.  Comments on the drafts are due by mid-September.

Also released in July were: ● revised bioequivalence recommendations for specific ANDA products ● an update on proposed changes to OGD’s question-based review (QbR) application approach, and ● clarification of the user fee policy regarding waivers and fee reductions.

The OGD July releases follow on the heels of a draft guidance on the content and format of ANDAs released in June (IPQ June 30, 2014).  In May, OGD put out a Q&A that is intended to clarify the June 2013 ANDA stability guidance (ibid.).

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