FDA's Center for Drug Evaluation & Research: 2015 Priorities & Accomplishments

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:
  • Issued draft “Nonproprietary Naming” guidance in 8/15
  • 1st biosimilar approval, for filgrastim
• Posting demographic information about newly approved drugs: “Drug Snapshots” program established
• Important guidances issued (many), for example:
  • Draft on Duchenne Muscular Dystrophy
  • Draft on Reporting Quality Metrics
• 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.