BRIEF—FDA's final guidance published on post-approval CMC changes

The US Food and Drug Administration (FDA) has issued its guidance document Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.

This final guidance aids original applicants and holders of approved new drug applications, abbreviated new drug applications, and biologics license applications with implementing chemistry, manufacturing, and controls (CMC) post-approval changes through the use of comparability protocols.

The types of CMC changes that can be addressed in a comparability protocol submission are described in the guidance, as well as the information to be included in the comparability protocol and how to implement and report the CMC changes.

Additionally, the guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products.