FDA's Center for Drug Evaluation & Research (CDER) 2015 Priorities & Accomplishments
Front Burner Priorities:
- GDUFA: meeting and exceeding performance goals; confident the division can reach steady state in two years
- Stabilization of new Office of Generic Drugs: accomplished
- Standup of Office of Pharmaceutical Quality: completed
- Completion of 2015 PAG agreement work: done
- Pharmacy compounding:
- Establishment of AC; multiple meetings
- Multiple draft and final Guidances issued
- Standup of Panorama (new IT system for workflow management, document and data access): accomplished--generic drug review process running on Panorama
- Respond to Sunscreen Innovation Act: have met all milestones
- Abuse-Deterrent Opioids Final Guidance: Issued 4/15
- Respond to Congressional requests on “21st Century Cures” legislation: done
Important Priorities:
- Established Sentinel Network in OSE: intent to utilize in routine drug safety activities
- OTC monograph reform: discussion of new approach with Congress and industry ongoing
- Sustainable model for ICH: completed, initial technical meeting held last week
- Biosimilars Program:
- Posting demographic information about newly approved drugs: “Drug Snapshots” program established
- Important guidances issued (many), for example:
- Build in-house OD capacity: New CDER leadership development program established
- GLP testing oversight function: established in OTS
- Management: implementation of LIRA, new budget management system
As stated by Janet Woodcock, MD, Director of CDER, at the FDA/CMS Summit for Biopharma Executives on December 14, 2015.