Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document entitled "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products." The guidance is intended 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). 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. The guidance announced in this notice finalizes the draft guidance, "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products," dated December 2017 and supersedes the document entitled "Guidance for Industry: Changes to an Approved Application: Biological Products," dated July 1997 (July 1997 guidance).