> ## Content Index
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# Stakeholder Comments on Cell, Gene Guidance
- URL: https://www.fdaweb.com/stakeholder-comments-on-cell-gene-guidance/
- Published: 2024-07-31T12:00:00.000Z
- Updated: 2026-09-14T14:36:58.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157476

The American Society of Gene & Cell Therapy says it would like FDA to clarify aspects of its draft guidance on considerations for using human- and animal-derived materials in the manufacture of cellular and gene therapy and tissue-engineered medical products. Its comment [letter](https://www.regulations.gov/comment/FDA-2024-D-1244-0021?ref=fdaweb.com) asks for clarifications on these themes: stage appropriateness, manufacturers and sponsors, and terminology. The letter also notes that outside of academic and small-scale manufacturing settings, the field is increasingly moving away from human- and animal-derived materials and toward chemically derived options. “We request FDA provide updated or new guidance on sponsors’ use of these alternate pathways,” it says.

In its [response](https://www.regulations.gov/comment/FDA-2024-D-1244-0024?ref=fdaweb.com), the Alliance for Regenerative Medicine says its members support much of the content of the draft with general feedback on two issues — information sharing: sponsor vs. supplier of materials, and risk assessments.

Pharmaceutical Research and Manufacturers of America (PhRMA) lists recommendations to improve the guidance, including areas where additional clarification would help facilitate consistent implementation of the guidance across the agency. The PhRMA recommendations cover **(1)** the definition and scope of human- and animal-derived materials, **(2)** phase appropriateness, **(3)** general recommendations on material supplier, supply, quality, and testing, and **(4)** recommendations related to regulatory submissions.

Each letter also includes specific line-by-line recommendations.