From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration (FDA) has issued draft guidance to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to the FDA.
Clarification regarding which elements of the CMC information constitute established conditions and where in an application these elements are generally expected to be described, should lead to a better understanding that certain CMC changes can be made solely under the pharmaceutical quality system (PQS) without the need to report to the FDA. For those changes that do require reporting, a better understanding of established conditions could allow for a more effective post-approval submission strategy by the regulated industry, according to the FDA draft guidance.
Specifically, the guidance describes those sections in a common technical document (CTD)-formatted application that typically contain information that meets the definition of established conditions and provides considerations for managing and communicating changes to the approved established conditions over the lifecycle of an approved product. The guidance is intended for applicants3submitting original new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to the FDA's Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
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