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December 5-6, 2017
Renaissance Washington DC Downtown,
Washington, D.C.

Driving Momentum Towards Approval of New Therapies

Thank you to all of those who attended FDA/CMS Summit 2016! Sign up for our email updates below for program updates and registration offers.

Be Prepared for the Wave of Public Policy Changes

Updates Directly From CDER and CMS
  • Regulatory Updates from Center for Drug Evaluation and Review (CDER) and the Insights into 2017
  • Updates on the Breakthrough Designation Program from the Office of New Drugs
  • Updates from CMS on Medicare Part B and Value-Based Pricing
Regulatory & Reimbursement Expertise
  • Biosimilar Review Timeless and Revisions to BSUFA
  • Priority Review Voucher Proliferation
  • Influence of Patient Advocacy Groups on Drug Review Processes
Drug Development Innovation
  • Global Regulatory Strategies in the Midst of Pandemics like Ebola and Zika
  • Challenges in Pediatric Drug Development
  • Regulatory Processes for Experimental Therapies

Media Partners

Sponsor the 2017 Event