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GUIDANCE DOCUMENT

Controlled Correspondence Related to Generic Drug Development March 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2014-D-1167
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.”  This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence.  This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests.  This guidance finalizes the draft guidance of the same title issued on December 22, 2022.  This guidance replaces the guidance “Controlled Correspondence Related to Generic Drug Development” issued on December 17, 2020.

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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-2014-D-1167.

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