
FDA Releases Guidance on CMC Post-approval Changes
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
FDA
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.
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