FDA TRACK Update: Interested in FDA’s work in biologics? Check out CBER’s FDA-TRACK Dashboard for their complete FY16 performance data.

On Track: The FDA-TRACK Monthly Newsletter

What’s New in November 2016

New performance data are available for the dashboards below.

Cross Agency

• FDA Safety and Innovation Act (FDASIA)-TRACK

Center for Biologics Evaluation and Research (CBER)

• CBER Dashboard: CBER continues to review serious adverse event reports in a consistent and timely manner.  In FY16, CBER reviewed 98% of serious adverse event reports within 90 days of submission. This exceed their annual target of 90% as well as their FY15 performance of 91%.   

Center for Tobacco Products (CTP)

• CTP Dashboard: The number of visits to www.fda.gov/tobacco during the month reached 424,315 visits at the end of FY16 Q3, a 19% increase compared to the end of FY15 Q3.  CTP continues to maximize their potential and positively impact public health through their communication about CTP’s activities, public education campaigns, and key messages.                            

Office of the Commissioner (OC)

• Office of Operations (OO) Dashboard: The Office of Finance, Budget, and Acquisition (OFBA) revised its small business contract award measures to ensure annual targets are met. The measures now track the number of contracts awarded to small businesses in five categories: 1) small businesses; 2) small disadvantaged businesses; 3) woman-owned small businesses; 4) historically underutilized business zones (Hub Zone); and 5) service disabled veteran-owned businesses.

December 2016 Upcoming Performance Data Updates

• Center for Drug Evaluation and Research (CDER)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVM)
• Office of Regulatory Affairs (ORA)
• Office of International Programs (OIP)
• Office of the Commissioner (OC) Administrative Offices