Rx-360 Summary of Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products

Recent FDA draft guidance has been developed to address the “lack of clarity” with respect to what chemistry, manufacturing and controls (CMC) information in a marketing application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. The guidance is intended to promote a better understanding of CMC changes that can be made solely under the Pharmaceutical Quality System without the need to report to FDA. Sections of the common technical document (CTD) that typically contains information meeting the definition of an established condition are also highlighted.

To view or download the FDA Guidance, click here

To view or download the Rx-360 Summary of the Guidance, click here