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# Guide on Cell, Gene Therapy Manufacturing Changes
- URL: https://www.fdaweb.com/guide-on-cell-gene-therapy-manufacturing-changes/
- Published: 2023-07-14T12:00:00.000Z
- Updated: 2026-09-14T18:44:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154881

*Federal Register* notice: FDA is making available a draft guidance entitled “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CGT) Products.” The document provides recommendations on product comparability and the management of manufacturing changes for investigational and licensed CGT products. It also offers the agency’s current thinking on management and reporting of manufacturing changes for CGT products based on a life-cycle approach, and comparability studies to assess manufacturing changes’ effect on product quality. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-14917.pdf?ref=fdaweb.com).