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# Guide on Comparability Protocols
- URL: https://www.fdaweb.com/guide-on-comparability-protocols/
- Published: 2022-10-14T12:00:00.000Z
- Updated: 2026-09-14T18:03:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152972

*Federal Register* notice: FDA has made available a final guidance entitled “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” The document says that in many cases submission and approval of a comparability protocol will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if it were not used. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-10-14/pdf/2022-22334.pdf?ref=fdaweb.com).