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Strategic U.S. Regulatory Considerations for Drug Development

Dr. Kusuma Mallikaarjun, Director, PPD Regulatory Consulting  who joined us to lead the discussion into Strategic U.S. Regulatory Considerations for Drug Development for Serious & Life Threatening Medical Conditions.

Download this presentation to find out more about:

  • U.S. regulatory options for expedited development of products to treat serious medical conditions
  • Comparison of expedited development options
  • Strategic regulatory algorithm to identify applicable expedited drug development and other regulatory options
  • Timing and process for obtaining breakthrough therapy and fast track designations 
  • Current state of Breakthrough Designations
  • Intersection of expedited development options with Orphan Drug designation option 
  • Case studies: Gazyva and Sovaldi

…and much more!

Download the presentation by filling in the form to your right


World Orphan Drug Congress USA team

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