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FDA Releases Draft Guidance on ANDA Content and Format as Efforts Continue to Clarify and Streamline Review Process Under GDUFA

Jun 30th, 2014

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A draft guidance on the content and format of abbreviated new drug applications (ANDAs) is the most recent effort by the Office of Generic Drugs (OGD) to clarify and streamline the ANDA process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA).  The draft was released in mid-June for a 60-day comment period.

In May, OGD released a Q&A guidance that is intended to clarify the June 2013 ANDA stability guidance.

Also in the pipeline nearing release are draft guidances on ANDA: ● amendments ● supplements, and ● controlled correspondences under GDUFA.

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