A Safety Concern is a significant issue related to the safety of a medicinal product. It can take the form of an identified risk, a potential risk that requires close monitoring, or the absence of essential information needed to assess a product’s safety profile. Safety concerns are systematically identified, characterized, and tracked in documents such as the Development Safety Update Report (DSUR), Risk Management Plan (RMP), and Periodic Safety Update Report (PSUR). These reports play a crucial role in ensuring the ongoing assessment and management of a product’s safety throughout its lifecycle.
Confounding by Indication
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