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# FDA Updates CRL Guidance Performance Goals
- URL: https://www.fdaweb.com/fda-updates-crl-guidance-performance-goals/
- Published: 2022-12-15T12:00:00.000Z
- Updated: 2026-09-14T18:09:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153404

FDA has published a revised guidance, *Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe*, to assist ANDA applicants in responding to complete response letters. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/failure-respond-anda-complete-response-letter-within-regulatory-timeframe-guidance-industry?ref=fdaweb.com) revises a 7/2022 guidance by incorporating performance goals outlined in the GDUFA 3 commitment letter.

The agency says it expects the guidance will promote efforts to address deficiencies faster, make the process for submitting and reviewing extension requests more efficient and predictable, and allow FDA to focus its resources on ANDA assessment.