# Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-use-of-human-and-animal-derived-materials-in-the-manufacture-of-cell-and-gene-therapy-and-tissue-engineered-medical-products/3d5c2c78-6224-49f7-8c61-e72d9219b413

> FDA guidance document: Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products. Issue date: April 29, 2024. Get complete insights and analysis.

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## Details

- Title: Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2024-04-29
- Last Changed: 2024-05-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-1244">FDA-2024-D-1244</a>

## Related Documents

- [Potency Assurance for Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/potency-assurance-for-cellular-and-gene-therapy-products/2a9b0d81-9dd5-43cf-994c-ac0df102c216)
- [Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products/18812f43-d054-46e4-b040-2e02c42fb4a3)
- [Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/manufacturing-changes-and-comparability-for-human-cellular-and-gene-therapy-products/b4919edd-67a6-490a-ab51-aa1a3c93944e)