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# Comments Extended on Cell, Gene Therapies
- URL: https://www.fdaweb.com/comments-extended-on-cell-gene-therapies/
- Published: 2023-08-23T12:00:00.000Z
- Updated: 2026-09-14T18:52:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155162

*Federal Register* notice: FDA is extending the comment period for a 7/14 notice that announced the availability of a draft guidance entitled “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CGT) Products.” The [document](https://www.fda.gov/media/170198/download?ref=fdaweb.com)’s purpose is to share the agency’s current thinking on **(1)** management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and **(2)** comparability studies to assess the effect of manufacturing changes on product quality. Electronic or written comments on the draft can now be submitted until 11/13\. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-18235.pdf?ref=fdaweb.com).