Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Prior to the launch of BEST, CBER utilized Sentinel for monitoring CBER regulated products. Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative. More information on Sentinel can be found on the Sentinel webpage.
National Evaluation System for health Technology (NEST)
To more efficiently generate better evidence for medical device evaluation and regulatory decision-making, the FDA is collaborating with medical device stakeholders to build the National Evaluation System for health Technology (NEST). In August 2016, the FDA awarded a cooperative agreement to the Medical Device Innovation Consortium (MDIC) to establish a Coordinating Center for NEST (NESTcc). The NESTcc provides governance for the NEST ecosystem, oversees infrastructure building, promotes standards, and monitors progress. More information on NESTcc can be found on the NESTcc webpage.
CBER collaborates with a number of federal agencies including Centers for Medicare & Medicaid Services (CMS), Veterans Administration (VA), and Centers for Disease Control and Prevention (CDC) through inter-agency agreements to broaden its surveillance activities and to evaluate safety and effectiveness of its regulated products, namely biologics. SafeRx program is an example of one such collaboration between FDA and CMS utilizing Medicare and Medicaid databases for surveillance of biologics. The CDC and FDA oversee the Vaccine Adverse Event Reporting System (VAERS) which is a passive vaccine safety surveillance program. FDA also has a close collaboration with the CDC Vaccine Safety Datalink (VSD) program which is an active vaccine surveillance program. The VA and FDA perform joint surveillance activities on vaccines, and other biologics.