Biologics Sentinel Initiative Projects

Biologics Sentinel Initiative Projects
The FDA Authorization Act of 2007 mandates the FDA to develop an active surveillance program to monitor the safety of drugs and vaccines once they are available for use in the general population. In line with the goals of this initiative, the FDA, CDC and other Federal and private partners conduct active surveillance, in addition to full epidemiologic studies, to monitor and improve vaccine safety. The purpose of active safety surveillance is to rapidly identify signals of potential excess risk of adverse outcomes following introduction of a drug or vaccine into clinical practice. Electronic data, including but not limited to claims data, are often used for active surveillance of large medical databases. Once a signal of a potential excess risk is detected by the surveillance system, adjudicated, and validated, appropriate epidemiologic studies should be conducted to confirm or refute the association.

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Biologics Sentinel Initiative Projects