> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Generic Drug Correspondence Guidance
- URL: https://www.fdaweb.com/generic-drug-correspondence-guidance/
- Published: 2017-11-02T12:00:00.000Z
- Updated: 2026-09-14T22:59:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140035

FDA has issued a draft guidance, *Controlled Correspondence Related to Generic Drug Development*, with information on the process by which generic drug manufacturers and related industry or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 to FDA controlled correspondence requesting information related to generic drug development. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM583436.pdf?ref=fdaweb.com) also describes the agency’s process for providing communications related to such correspondence.

When finalized, the guidance replaces a 9/2015 guidance that was issued as part of the agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA 1). The revision incorporates program enhancements related to the review of controlled correspondence to which FDA committed and industry agreed as part of the GDUFA 2 reauthorization this year.