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GUIDANCE DOCUMENT

ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry October 2022

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2014-D-0901
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).  The guidance explains how the Generic Drug User Fee Amendments (GDUFA) relates to PAS submissions.  The guidance revises the guidance of the same title issued in October 2017. This revision is being issued to incorporate the performance goals currently outlined in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years [Fiscal Years [FYs]] 2023-2027 (GDUFA III commitment letter) that FDA has agreed to meet and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the performance goals in the GDUFA III commitment letter. 

 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0901.

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