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.

Your First and Only Chance to Hear the FDA & CMS Address Payers and Pharma Under One Roof

 

Introducing the FDA/CMS Summit for Payers

The Full Agenda is Now Available | Download Now! 

 
 
Hear the challenges and opportunities on key issues in order to succeed in a patient-centric environment. Plus:

• Get face-to-face access to the top regulatory thought leaders and policy makers from FDA and CMS
• Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
• Walk away with practical, real life lessons from some of the most experienced payers and healthcare executives on how they are dealing with the changes
• Benchmark your operational, regulatory and strategy against all the major health plans

Meet Regulators from FDA and CMS:

• Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
• John K. Jenkins, MD, Director of the Office of New Drugs, Center for Drug Evaluation and Research, FDA
• Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group (CAG), CMS
• Niall Brennan, Acting Director, Offices of Enterprise Management (OEM), CMS


Collaborate with C-Level Healthcare Leaders:

• Dr. Trent T. Haywood, MD, JD, Chief Medical Officer & SVP, Office of Clinical Affairs, Blue Cross and Blue Shield Assc.
• Dr. Claire Levesque, Chief Medical Officer for Commercial Products, Tufts Health Plan
• Dr. Richard Migliori, MD, Executive VP, Medical Affairs, Chief Medical Officer, UnitedHealth Group
• David Polakoff , MD, M.Sc, Chief Medical Officer & Associate Dean, Commonwealth Medicine Director, Center for Health Policy and Research, University of Massachusetts Medical School   
• William Winkenwerder, Jr.,  Former CEO, Highmark, Inc.
• Kevin Volpp, MD, PhD, Founding Director, Center for Health Incentives and Behavioral Economics, Leonard Davis Institute


Register now with the code XP1917BLOG and take an additional $100 off the current rate - $500 in total savings. Register here.