[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA released a draft guidance on “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” on June 1 for a 60-day comment period. The Federal Register notice states that the guidance was developed to address the “lack of clarity” with respect to what CMC information in a marketing application constitutes an “established condition” or a “regulatory commitment” that, if changed following approval, requires reporting to FDA. The 17-page draft 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 CTD that typically contain information meeting the definition of an established condition are highlighted.