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# Final Guide on Reporting Biologic CMC Changes
- URL: https://www.fdaweb.com/final-guide-on-reporting-biologic-cmc-changes/
- Published: 2021-12-10T12:00:00.000Z
- Updated: 2026-09-14T17:25:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150748

*Federal Register* notice: FDA has made available a final guidance entitled *CMC* *Postapproval* *Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports*. The guidance outlines the types of changes to be documented in annual reports: changes that FDA generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-10/pdf/2021-26734.pdf?ref=fdaweb.com).