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# Expedited Programs for Regenerative Medicines Draft Guidance
- URL: https://www.fdaweb.com/expedited-programs-for-regenerative-medicines-draft-guidance/
- Published: 2017-11-17T12:00:00.000Z
- Updated: 2026-09-14T23:02:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140159

*Federal Register* notice: FDA makes available a draft guidance on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The draft describes the expedited programs available to sponsors of these therapies for serious or life-threatening diseases or conditions; how CBER will work with sponsors and encourage flexibility in clinical trial designs for such products; and the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-17/pdf/2017-24837.pdf?ref=fdaweb.com).