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GUIDANCE DOCUMENT

Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry September 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
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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Submit Comments Online

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-2012-D-0881.

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