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Monday, January 5, 2015

Dr. Janet Woodcock's Internal Presentation to the FDA staff for 2015 priorities include implementing drug compounding statutory provisions and recruiting for 600 job vacancies

2015 CDER Priorities -
Dr. Janet Woodcock gave an internal presentation to FDA staff on her priorities for fiscal year 2015.  FDAnews published the slides.
Front burner priorities are:
  1. Implement drug compounding statutory provisions
  2. GDUFA review goals and backlog (about 3,000) reduction
  3. Continue “stand up” of OGD super office
  4. “Stand up” Office of Pharmaceutical Quality (OPQ)
  5. Implement Program Alignment Group agreement with the Office of Regulatory Affairs
  6. Implement new IT system for process, data and document management
  7. 21st Century Cures legislative activities
  8. Drug advertising and promotion re-evaluation
  9. Sunscreen Innovation Act implementation
  10. Respond to Ebola
  11. Issue final guidance on abuse-deterrent opioids
  12. Recruit more staff for 600 vacancies
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