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:
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U.S. regulatory options for expedited development of products to treat serious medical conditions
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Comparison of expedited development options
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Strategic regulatory algorithm to identify applicable expedited drug development and other regulatory options
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Timing and process for obtaining breakthrough therapy and fast track designations
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Current state of Breakthrough Designations
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Intersection of expedited development options with Orphan Drug designation option
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Case studies: Gazyva and Sovaldi
…and much more!
Download the presentation by filling in the form to your right
Thanks,
World Orphan Drug Congress USA team