Docket Number:
FDA-2012-D-0881
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as 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))

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0881.