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# Guidance on ANDA Post-complete Response Meetings
- URL: https://www.fdaweb.com/guidance-on-anda-post-complete-response-meetings/
- Published: 2018-12-03T12:00:00.000Z
- Updated: 2026-09-15T00:48:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142942

FDA has released a [guidance ](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM580175.pdf?ref=fdaweb.com)entitled “Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations on how such meetings are intended to clarify deficiencies identified in a CRL referencing an ANDA. Post-CRL meetings should be requested in writing by an ANDA applicant pursuant to the procedures described in the guidance. The guidance also is intended to assist applicants in generating and submitting a request for a post-CRL meeting and the associated meeting package to FDA as discussed in the FDA Reauthorization Act of 2017.