# Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postapproval-methods-to-capture-safety-and-efficacy-data-for-cell-and-gene-therapy-products-draft-guidance-for-industry/d076649d-1260-49fb-bc96-30f59be10ea0

> FDA guidance document: Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry. Issue date: September 24, 2025. Get complete insights and analysis.

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## Details

- Title: Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry
- 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: 2025-09-24
- Last Changed: 2025-11-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-3049">FDA-2025-D-3049</a>

## Related Documents

- [Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products](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)
- [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)