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  5. CBER’s Sentinel Program
  1. Biologics Post-Market Activities

CBER’s Sentinel Program

FDA’s Sentinel Initiative was launched in 2008 in response to a mandate in the FDA Amendments Act (FDAAA) of 2007 to establish a national risk identification and analysis system using electronic healthcare data to monitor the safety of drugs, biologics and devices. In line with these goals, CBER has launched several projects within Sentinel to improve postlicensure safety surveillance of vaccines and other biologics.



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