
FDA Releases Guidance on CMC Changes for Biologics
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
FDA has released
The draft guidance describes which sections of a common technical document (CTD)-formatted application that define established conditions and “provides considerations for managing and communicating changes to the approved established conditions over the lifecycle of an approved product.” FDA does say in the draft guidance that “for change management activities that do not require reporting to the Agency, any related risk evaluation and product-specific knowledge used to support change management decisions should be made available upon FDA request (e.g., upon site inspection, record request).”
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