# Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/chemistry-manufacturing-and-controls-changes-to-an-approved-application-certain-biological-products-guidance-for-industry/27111644-ec6f-4414-997c-1a3ca9f85b8a

> FDA guidance document: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products:  Guidance for Industry. Issue date: June 21, 2021. Get complete insights and analysis.

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## Details

- Title: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2021-06-21
- Last Changed: 2021-08-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1995-D-0288">FDA-1995-D-0288</a>

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