Wednesday, 29 July 2015

FDA - Reportable CMC Changes for Approved Drug and Biologic Products



FDA has issued a new guidance document: “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products - Guidance for Industry.”

This guidance describes those sections in a common technical document (CTD)- formatted application that typically contain information that meets the definition of established conditions, and provides considerations for managing and communicating changes to the approved established conditions over the lifecycle of an approved product.

For further details see FDA.

Posted by Tim Sandle