lunes, 1 de julio de 2013

U.S. Food & Drug Administration (FDA) FDA-TRACK Update

FDA-TRACK is an agency-wide performance management system that monitors over 100 FDA program offices through key performance measures and projects.  These measures and projects are updated quarterly on the website.
What's New with FDA-TRACK
June 2013 Performance Data Updates
New performance data is available for the dashboards below.  
Center for Biologics Evaluation and Research (CBER)
  • FDA-TRACK CBER DashboardCBER continues to meet program measure targets to advance its six strategic priorities: 1) increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases; 2) improve global public health through international collaboration including research and information sharing; 3) enhance the ability of advances in science and technology to facilitate development of safe and effective biological products; 4) ensure the safety of biological products; 5) advance regulatory science and research; and 6) manage for organizational excellence and accountability. 

Center for Food Safety and Applied Nutrition (CFSAN)
  •  FDA-TRACK CFSAN Dashboard
    • During FY2013 Quarter 2, the Office of Food Safety (OFS) reviewed 84% of regulatory cases within the timeframe given to OFS in the Case Management System (CMS), exceeding its 80% target.
    • The Office of Nutrition, Labeling and Dietary Supplements (ONLDS) continues to review 100% of its infant formula notification reviews and new dietary ingredient notification reviews within the required timeframes (75 and 90 days, respectively).
    • To date during FY2013, the Office of Regulatory Science (ORS) has continually exceeded its target by reviewing 95% of analytical package reviews received via FDA's electronic CMS that meets Office of Compliance (OC) timeframes specified in CMS.  
July 2013 Upcoming Performance Data Updates

General Program Updates
  • Most Popular Quarterly Content – Visit this page for FY 2013 Quarter 2 most visited and clicked content.
  • Quarterly Briefing Summaries – Visit this page for public summaries of accomplishments discussed at each FDA-TRACK briefing. We post summaries approximately 30 business days after each quarterly briefing.

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