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:
- Implement drug compounding statutory provisions
- GDUFA review goals and backlog (about 3,000) reduction
- Continue “stand up” of OGD super office
- “Stand up” Office of Pharmaceutical Quality (OPQ)
- Implement Program Alignment Group agreement with the Office of Regulatory Affairs
- Implement new IT system for process, data and document management
- 21st Century Cures legislative activities
- Drug advertising and promotion re-evaluation
- Sunscreen Innovation Act implementation
- Respond to Ebola
- Issue final guidance on abuse-deterrent opioids
- Recruit more staff for 600 vacancies
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