Tuesday, October 21, 2014

Center for Drug Evaluation and Research, New Drug Review: 2013 Update

FDA/CMS Summit 2014 speaker John K. Jenkins, M.D., Director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.


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!

To access the complete presentation from Dr. Jenkins, click here.

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.

No comments: