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

Sponsors developing drugs/biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for Orphan Drug Designation with the FDA, EMA and other local health authorities.  However, due to varying regional and local regulations, ODD applications should be considered from different angles.  

In this webinar, regulatory experts working with FDA, EMA, MHRA and Swissmedic will share their experiences navigating the requirements, benefits, and nuances of ODD applications and discuss specific examples of ODD applications in various regions.

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