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# BLA Chemistry, Manufacturing and Control Changes Guide
- URL: https://www.fdaweb.com/bla-chemistry-manufacturing-and-control-changes-guide/
- Published: 2021-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:04:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149601

*Federal Register* notice: FDA has made available a final guidance entitled *Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products*. The document is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls information to an approved BLA. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-13392.pdf?ref=fdaweb.com).