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.

Sentinel

• Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines
• Sentinel Website
• FDA Basics Webinar: FDA CBER Mini-Sentinel Program

Gardasil

• FDA Sentinel study finds no association between venous thromboembolism and Gardasil vaccination