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FDA ANDA Submissions Guidance - Prior Approval Supplements under GDUFA

  • By: Staff Editor
  • Date: April 07, 2017
  • Source: http://www.fda.gov
Abstract:

FDA ANDA Submissions Guidance – Prior Approval Supplements under GDUFA

US FDA has issued a guidance, in October 2016, to aid pharma companies preparing to submit prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the FD&C Act. The guidance further explains how the GDUFA relates to PAS submissions. Specifically, the guidance focuses on the following key areas:

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