Below you can access his presentation from last December at the FDA/CMS Summit. In his presentation, Dr. Jenkins addresses these key topics:
• How is CDER doing with regard to meeting PDUFA goals?
• What are the trends in new drug approvals?
o IND activity, NME submissions, and NME approvals
• Implementation of PDUFA V/FDASIA
o “Program” for NME review
o Breakthrough Therapy Designation Program
• Update on PMCs/PMRs
Dr. Jenkins also addresses the main themes in new drug review:
• Continuing resolution – the new normal
• PDUFA V; hold the additional resources
• FDASIA implementation; what new resources?
• The “Program” takes off
• Breakthroughs breaking out
• Sequestration bites
• Shutdown shuffle
• Patient-focused drug development refocused
• “Slow down?” in NME approvals – not really
• Despite challenges, new drug review program successes continue!
Join us this December 11-12 in Washington D.C. to hear Dr. Jenkins address these challenges for the upcoming year. This is an event you do not want to miss. Register now and save $300 off the standard rate, just use the code XP1917BLOG at checkout. To register, click here.