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# Generic Drug Controlled Correspondence Guidance
- URL: https://www.fdaweb.com/generic-drug-controlled-correspondence-guidance-2/
- Published: 2020-12-16T12:00:00.000Z
- Updated: 2026-09-14T16:40:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148313

FDA has published a guidance, *Controlled Correspondence Related to Generic Drug Development*, with information on the process by which generic drug manufacturers and related industry or their representatives can submit controlled correspondence to FDFa requesting information related to generic drug development. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/controlled-correspondence-related-generic-drug-development-guidance-industry?utm%5Fmedium=email&utm%5Fsource=govdelivery) also describes the agency's process for providing communications relating to such correspondence.

The guidance replaces a 9/2015 guidance that was issued as part of the agency’s GDUFA 1 implementation. The new guidance incorporates program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the GDUFA 2 reauthorization, the agency says.