Top tips for a successful EU Orphan Drug Designation application
We regularly assist clients who have a US orphan drug designation (ODD) and wish to obtain an EU orphan drug designation. Whilst most companies understand that there are differences between the US and EU applications, and are aware of the guidance on the EMA website, we often find similar questions arise and the same deficiencies occur in EU orphan drug applications (ODAs) that are drafted for our review.