FDA: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products

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. Clarification regarding which elements of the CMC information constitute established conditions and where in an application these elements are generally expected to be described, should lead to a better understanding that certain CMC changes can be made solely under the Pharmaceutical Quality System (PQS) without the need to report to FDA. For those changes that do require reporting, a better understanding of established conditions could allow for a more effective post-approval submission strategy by the regulated industry.