National Comprehensive Cancer Network

Video Modules

FDA Watch

Taped March 9, 2011 in Hollywood, Florida

This module addresses FDA considerations such as:
  • FDA/CMS Parallel Review: Will it happen, How often and Implications for the Introduction of drugs and biologics
  • Accelerated Approval and Phase IV Study requirements: Will the FDA continue to ratchet down on this “Requirement”
  • Supplemental Indications: Can outside expertise (e.g., NCCN) supplement ODAC and FDA; Would FDA be open to this as a collaboration
  • Safety and Effectiveness: Will comparative effectiveness and cost considerations be added as data requirements
  • REMS: FDA’s view after initial introductions of REMS programs and feedback
  • Clinical Outcomes as Regulatory End Points in Cancer Care; Is progression free survival enough, e.g., with a driver gene is substantial response rate sufficient


  • Scott  Gottlieb, MD, American Enterprise Institute (Moderator)
  • William  T.  McGivney, PhD, National Comprehensive Cancer Network (NCCN) (Moderator)
  • Al  B.  Benson III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Randy  Burkholder, Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Kathleen  M.  Sanzo, Morgan, Lewis & Bockius FDA and Healthcare Practice
  • Elizabeth  Thompson, Susan G. Komen for the Cure

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File Size: 123 MB       Length: 73 minutes       Last Updated: 07/20/2011

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