# Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/chemistry-manufacturing-and-controls-flexibilities-for-developing-human-cellular-and-gene-therapy-products-for-a-biologics-license-application-guidance-for-industry/739ce951-2fb3-460d-bd26-98a07366db2f

> FDA guidance document: Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application:  Guidance for Industry. Issue date: May 05, 2026. Get complete insights and analysis.

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## Details

- Title: Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application:  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: 2026-05-05
- Last Changed: 2026-05-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-4692 ">FDA-2026-D-4692 </a>

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