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Thursday, October 20, 2016

FDA publishes guidance for industry: ANDA Submissions - Prior Approval Supplements Under GDUFA


The FDA published the final guidance for industry, “ANDA Submissions - Prior Approval Supplements Under GDUFA.”  This final guidance is intended to assist applicants preparing to submit prior approval supplements (PASs) and related amendments. The guidance explains how the Generic Drug User Fee Amendments of 2012 (GDUFA) relate to PAS submissions and clarifies how FDA handles PASs and amendments for ANDAs subject to the GDUFA performance metric goals. 
The draft version of this guidance was published in July 2014. The final guidance addresses comments received in the public comment period, and includes the following updates:




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