martes, 6 de agosto de 2013

FDA-TRACK Update: FDASIA One Year Anniversary Progress

FDA-TRACK is an agency-wide performance management system that monitors FDA programs through key performance measures and projects.  These measures are updated quarterly on the website.
What's New In July 2013
New performance data are available for the dashboards below.  
 Cross Agency
  • FDA Safety and Innovation Act (FDASIA)-TRACK With the passing of the one-year anniversary of FDASIA this month, FDASIA-TRACK has been updated to reflect progress to date. A couple of highlights include:
    • Completion of a strategy and implementation plan for advancing regulatory science for medical products in order to promote public health and advance innovation in regulatory decision-making.
    • Submission of a report to Congress on FDA’s small business assistance activities, including information on FDA's offices, partnership efforts with the Small Business Administration, outreach efforts to small businesses, and other specified topics.
  • Advisory Committees Dashboard
  • Freedom of Information Act (FOIA) Dashboard: The Division of Freedom of Information (DFOI) calculated that 2,541 FOIA requests were processed during FY 2013 Quarter 2, representing a 25% increase over FY 2013 Quarter 1 (2,034 requests processed).
  • Health Care Reform Dashboard: Section 3507, Presentation of Prescription Drug Benefit and Risk Information, remains on track for completion.
Center for Devices and Radiological Health (CDRH)
Office of International Programs (OIP) 
  • June 11, 2013: FDA-TRACK OIP Quarterly Briefing Summary 
  • OIP Dashboard: During the first two quarters of FY 2013, OIP completed 25 high priority inspections. High priority inspections are public health emergencies such as an outbreak, a user-fee driven issue, an issue pending a critical patent expiry, or an inspection spurred by a cause or special request.
Office of Regulatory Affairs (ORA)
  • June 11, 2013: FDA-TRACK ORA Quarterly Briefing Summary 
  • ORA Dashboard: The Office of Criminal Investigations (OCI) completed 93 criminal convictions during FY 2013 Quarter 2, bringing the fiscal year total to 140. The number of convictions increased by 98% in Quarter 2, achieving a record high for OCI since data collection for this measure began in fall 2010. To date in FY 2013, OCI has recovered over $2.7 million in fines and restitutions.
Office of Special Medical Products (OSMP)
  • OSMP Dashboard: During FY 2013 Quarter 2, the Office of Orphan Products Development (OOPD) completed 92% of its orphan drug designation reviews within its 90 day target.
Office of the Commissioner (OC)

August 2013 Upcoming Performance Data Updates 

General Program Updates
  • NEW! What’s New  – Visit this page for monthly FDA-TRACK updates.
  • Most Popular Quarterly Content – Visit this page for FY 2013 Quarter 3 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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