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# FDA Guide on CMC Postapproval Changes for BLAs
- URL: https://www.fdaweb.com/fda-guide-on-cmc-postapproval-changes-for-blas/
- Published: 2017-08-09T12:00:00.000Z
- Updated: 2026-09-14T22:39:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139349

*Federal Register* notice: FDA has made available a draft guidance on “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” The document provides recommendations to BLA holders, describing chemistry, manufacturing, and controls postapproval manufacturing changes that the agency 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.gpo.gov/fdsys/pkg/FR-2017-08-09/pdf/2017-16718.pdf?ref=fdaweb.com).