FDA Guidance for Industry: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
Title:
FDA Guidance for Industry: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
Origin/Publisher:
FDA
Content:
This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to FDA