Guidance on Drug/Biologic Comparability, CMC Info

Federal Register Notice: FDA is making available a draft guidance for industry entitled Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information. This document is a revised version of a draft guidance that published in 2/2003 entitled “Comparability Protocols: Chemistry, Manufacturing, and Controls Information.” A related draft guidance entitled Comparability Protocols — Protein Drug Products and Biological Products — Chemistry, Manufacturing, and Controls Information, that published in 9/2003 was withdrawn on 5/6/15. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls postapproval change(s) through the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. To view this notice, click here.