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# ANDA Complete Response Letter Guide
- URL: https://www.fdaweb.com/anda-complete-response-letter-guide/
- Published: 2022-07-25T12:00:00.000Z
- Updated: 2026-09-14T17:53:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152347

*Federal Register* notice: FDA is making available a final guidance entitled “Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.” The document is intended to assist applicants in responding to complete response letters (CRLs) on ANDAs. It provides information and recommendations about certain actions ANDA applicants can take after issuance of a CRL as well as the actions that FDA may take if the applicant fails to respond to a CRL. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-07-25/pdf/2022-15825.pdf?ref=fdaweb.com).