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:
  • 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.