> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Biologic CMC Post-Approval Changes
- URL: https://www.fdaweb.com/draft-guide-on-biologic-cmc-post-approval-changes/
- Published: 2017-08-08T12:00:00.000Z
- Updated: 2026-09-14T22:39:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139328

FDA has released for comment a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM570441.pdf?ref=fdaweb.com) on “CMC Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” The document provides recommendations on the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12\. Specifically, it describes chemistry, manufacturing, and controls (CMC) post-approval manufacturing changes that the agency generally considers to have a minimal potential to have an adverse effect on product quality.