us reguation

Strategic U.S. Regulatory Considerations for Drug Development for Serious & Life Threatening Medical Conditions

In Regulation & Government by Freya Smale

us reguationIn last week’s State of the Union (SOTU) address, President Barack Obama backed the Orphan Drug industry, and bought to the forefront of the nation something this industry has known for a while: medicine is becoming increasingly precise.

In light of State of the Union address, we took a look back at the discussions from the World Orphan Drug Congress USA 2014 and found this interesting presentation from Dr. Kusuma Mallikaarjun, Director, PPD Regulatory Consulting  who joined us to speak about 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!

Get your copy here!

If you are interested in finding out more about regulatory considerations for orphan drugs, then join us at the 5th Annual World Orphan Drug Congress USA in Washington D.C. in April 2015.

Visit the event website for more information. 

WODC 840X120