# Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/innovative-designs-for-clinical-trials-of-cellular-and-gene-therapy-products-in-small-populations-draft-guidance-for-industry/cd9be98c-6af4-4697-b410-093f03cd7dd5

> FDA guidance document: Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry. Issue date: September 24, 2025. Get complete insights and analysis.

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## Details

- Title: Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry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: 2025-09-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-3403">FDA-2025-D-3403</a>

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