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New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
FDA released guidance providing 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. The guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality. FDA, therefore, states that applicants should document these changes in an annual report.
A list of examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements is provided that FDA has determined to be of low risk to product quality. The guidance also provides examples of minor changes to be documented in an annual report that were previously published in FDA’s Scale-up and Postapproval Changes (SUPAC) guidance documents and other postapproval change CMC guidance documents.