# Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs):  Guidance for FDA Reviewers and Sponsors - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/content-and-review-of-chemistry-manufacturing-and-control-cmc-information-for-human-somatic-cell-therapy-investigational-new-drug-applications-inds-guidance-for-fda-reviewers-and-sponsors/b31bbe0c-42aa-4671-a86f-7bc15821926b

> FDA guidance document: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs):  Guidance for FDA Reviewers and Sponsors. Issue date: April 01, 2008. Get complete insights and analysis.

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## Details

- Title: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs):  Guidance for FDA Reviewers and Sponsors
- 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: 2008-04-01
- Last Changed: 2025-02-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0206">FDA-2008-D-0206</a>

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