- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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 of 2012 (GDUFA) relates to PAS submissions. The guidance also describes the performance metric goals outlined in the GDUFA Program Performance Goals and Procedures for fiscal years 2015 through 2017 (GDUFA I) and the GDUFA Reauthorization Performance Goals and Program Enhancements fiscal years 2018-2022 (GDUFA II) Commitment Letters that FDA has agreed to meet,2 and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.
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:
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-2014-D-0901.