cGMPs / QRM Process

FDA Publishes Draft Guidance on CMC Postapproval Changes


Jul 02, 2010

FDA has published "Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports." The document "provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report." Comments to the guidance should be submitted within 90 days.