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ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry July 2018

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) 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)).2 This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The guidance also describes how FDA should assess3 amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.

Submit Comments

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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