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Breakthrough or More of the Same? New Pathways and Exclusivities in FDA Approval Processes

December 16, 2013

The FDA has been under significant pressure to accelerate the market entry of medical products, and particularly those that address serious and life-threatening conditions. To that end, recent statutory changes include new review designations and pathways, as well as new and enhanced authorities and exclusivities. The Biologics Price Competition and Innovation Act created a new pathway for biosimilar approvals and associated exclusivities. Concurrently, FDA has made significant changes to its medical device clearance and approval processes.

This program will provide an update on these developments, the policy thinking behind them and experience to date. The panelists will consider:

  • “Breakthrough” designation, fast track and accelerated approval
  • Qualified infectious disease products and associated exclusivity
  • FDA consultation with experts and patient groups in product review processes
  • Rare pediatric disease priority review voucher program
  • Modification of the device de novo application process
  • What's next? Current thinking on potential new pathways, incentives, and exclusivity changes.

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