Orphan Drug Designation - The Considerations, The Rewards, and How They Differ Between The US and Europe 

Maximize the Potential of Your Rare Disease Treatment.


Orphan Drug Designation (ODD) can be a valuable tool for sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or condition. However, navigating the requirements, benefits, and nuances of ODD applications can be challenging, especially with the varying regulations of the FDA, EMA, MHRA and Swissmedic. 

  • How to navigate the requirements, benefits, and nuances of ODD applications 
  • The key differences between the US and Europe in terms of ODD applications 
  • Specific examples of ODD applications in various regions 
 Don't miss out on this opportunity to learn from the experts and take your rare disease treatment development to the next level. Register now for immediate access to the on-demand webinar recording.