# Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry – FDA Guidance Source: https://www.keypedia.com/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. --- ## 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: FDA-1995-D-0288 ## Related Documents - [Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers](https://www.keypedia.com/guidances/guidance-document/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questions-and-answers/f3f2a490-2ac9-47b1-82ca-d3a550511aaf) - [Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/interacting-with-the-fda-on-complex-innovative-trial-designs-for-drugs-and-biological-products-guidance-for-industry/915195b1-fcb7-4359-b741-f4ca3ed67b13) - [Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/testing-for-biotin-interference-in-in-vitro-diagnostic-devices-guidance-for-industry/1a6a74f2-3b19-490b-9847-11a56bd093bf)