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# Draft Guide on Cell/Gene Therapy Considerations
- URL: https://www.fdaweb.com/draft-guide-on-cell-gene-therapy-considerations/
- Published: 2024-04-30T12:00:00.000Z
- Updated: 2026-09-14T14:29:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156881

*Federal Register* notice: FDA is making available a draft document entitled “Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.” The document provides manufacturers of cellular and gene therapy and tissue-engineered medical products with recommendations on assuring the safety, quality, and identity of materials of human and animal origin used in their manufacturing. In addition, recommendations are provided on the chemistry, manufacturing, and control information submitted in an IND relating to the use of human- and animal-derived materials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-30/pdf/2024-09286.pdf?ref=fdaweb.com).