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# Guidance on Drug/Biologic Comparability, CMC Info
- URL: https://www.fdaweb.com/guidance-on-drug-biologic-comparability-cmc-info/
- Published: 2016-04-20T12:00:00.000Z
- Updated: 2026-09-14T20:56:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135435

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information*. This document is a revised version of a draft guidance that published in 2/2003 entitled “Comparability Protocols: Chemistry, Manufacturing, and Controls Information.” A related draft guidance entitled *Comparability Protocols — Protein Drug Products and Biological Products — Chemistry, Manufacturing, and Controls Information*, that published in 9/2003 was withdrawn on 5/6/15\. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls postapproval change(s) through the use of a comparability protocol. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-20/pdf/2016-09137.pdf?ref=fdaweb.com).