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.
Vaccines, Blood & Biologics
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Avenue
Building 71 Room 3103Silver Spring, MD 20993-0002