FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
By Mark Durivage, Quality Systems Compliance LLC
On June 21, 2021, the FDA released a new guidance, Chemistry, Manufacturing, and Controls Changes (CMCs) to an Approved Application: Certain Biological Products, to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in 21 CFR 601.12 Changes to an approved application. This guidance finalizes the draft guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products, dated December 2017, and supersedes the guidance titled Guidance for Industry: Changes to an Approved Application: Biological Products, dated July 1997. The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under 21 CFR 601.12.