Federal Register Notice: FDA is making available a draft guidance for industry entitled Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products. Its purpose is to provide applicants of NDAs, ANDAs and BLAs with FDA’s current thinking on established conditions (i.e., the chemistry, manufacturing, and controls information in a submission that would require reporting to the agency if changed for approved drug and biologic products, per the current regulations). This guidance also describes those sections of a common technical document formatted application that typically contain information that meets the definition of established conditions, and provides considerations for managing changes to established conditions over the life cycle of an approved product. To download this draft guidance, click here. To view this notice, click here.