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

This guidance has been developed to address the lack of clarity with respect to what chemistry, 17 manufacturing, and controls (CMC) information in a marketing application constitutes an 18 established condition or a “regulatory commitment” that, if changed following approval, requires 19 reporting

Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news