# Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs):  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/chemistry-manufacturing-and-control-cmc-information-for-human-gene-therapy-investigational-new-drug-applications-inds-guidance-for-industry/39f9f187-0a0c-44a1-8781-ebb975125baa

> FDA guidance document: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs):  Guidance for Industry. Issue date: January 28, 2020. Get complete insights and analysis.

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## Details

- Title: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs):  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: 2020-01-28
- Comment Close Date: 2018-10-10
- Last Changed: 2020-01-31
- Docket Number: <a href="https://www.regulations.gov/docket/2008-D-0205">2008-D-0205</a>

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