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

December 16, 2015

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.




Agency Alerts General Regulatory

December 16, 2015

FDA’s Center for Drug Evaluation & Research: 2016 Priorities

FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus Front Burner Priorities: Negotiate PDUFA 6 agreements Negotiate GDUFA 2 agreements Negotiate a second BSUFA program...

Read More
Agency Alerts General Regulatory

December 16, 2015

FDA Releases CDER’s 2017 Guidance Agenda

Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...

Read More
Generic Drugs General Regulatory

December 16, 2015

FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products

Throughout 2017, the FDA focused its attention on the regulation of generic drug products.  In 2015, the Agency issued only two generic-related guidance documents.  In 2016, there were seven.  In...

Read More