FDA Releases Guidance on CMC Changes for Biologics

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The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.


FDA has released draft guidance clarifying which chemistry, manufacturing, and controls (CMC) information in a marketing application requires reporting to FDA if changed after approval. FDA believes that clarifying the requirements will help applicants submitting original new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to better understand which CMC changes can be made under the Pharmaceutical Quality System and do not need to be reported to FDA.


The draft guidance describes which sections of a common technical document (CTD)-formatted application that define established conditions and “provides considerations for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 FDA does say in the draft guidance that “for change management activities that do not require reporting to the Agency, any related risk evaluation and product-specific knowledge used to support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).”

Source: FDA.gov