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FDA: Guidance for Industry CMC Post approval Manufacturing Changes To Be Documented in Annual Reports

10.04.2014
This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely have a minimal potentia l to have an adverse effect on product quality.