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# Draft Guide on Generic Drug Complete Response Meetings
- URL: https://www.fdaweb.com/draft-guide-on-generic-drug-complete-response-meetings/
- Published: 2017-10-13T12:00:00.000Z
- Updated: 2026-09-14T22:55:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139863

FDA has posted a draft guidance on “Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations to industry about such meetings to clarify deficiencies identified in a CRL. It provides procedures to promote well-managed post-CRL meetings and to ensure that the meetings are scheduled and conducted in accordance with the timeframes set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements. To view the guidance, click [here](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM580175.pdf?ref=fdaweb.com).