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Orphan Drug Designations – Are the EMA and FDA looking for the same Information?

Whilst working on a recent European application for an Orphan Drug Designation (ODD) for a rare neurological condition that was being made to the EMA, I noticed that there was a markedly lower number of ODD application approvals for that particular indication in the EU than in the US. I then looked at some other rare diseases, in case this was a peculiarity of this specific rare neurological condition but, no, for other indications there were also fewer registrations for ODDs in the EU than in the US. Susan McGoldrick from QCTR reflects on Orphan drug designations.….pdf