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GUIDANCE DOCUMENT

ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry September 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 2 Guidance
Docket Number:
FDA-2017-D-5670
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s assessment goal dates. This guidance supersedes the July 2018 guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5670.

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