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# Guide on Rescinding Breakthrough Therapy Designations
- URL: https://www.fdaweb.com/guide-on-rescinding-breakthrough-therapy-designations/
- Published: 2022-06-24T12:00:00.000Z
- Updated: 2026-09-14T17:49:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152158

*Federal Register* notice: FDA is making available a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation.” The guidance says that given the resource-intensive nature of the breakthrough therapy program, the agency periodically assesses whether designated products continue to meet the designation criteria. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-24/pdf/2022-13528.pdf?ref=fdaweb.com).