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FDA Issues Industry Guidance for Prior Approval Supplements

November 7, 2016

The US Food and Drug Administration (FDA) has issued Guidance for Industry ANDA Submissions – Prior Approval Supplements Under Generic Drug User Fee Amendments of 2012 (GDUFA).

The industry guidance aims to represent FDA’s current thinking and recommendations on prior approval supplements (PASs). This document provides assistance to the industry on how to prepare and submit to FDA PASs and amendments to PASs for abbreviated new drug applications (ANDAs).

Specifically, this document presents how GDUFA performance metric goals apply to:

  • A PAS subject to the refuse-to-receive (RTR) standards
  • A PAS that requires an inspection
  • A PAS for which an inspection is not required
  • An amendment to a PAS
  • Other PAS-related matters

The document was released on October 17, 2016.