To achieve orphan designation, it takes more than just proving your drug is intended to treat a rare disease. Besides prevalence data, in EU you will need to show potential for a significant benefit compared to any existing treatments including non-pharmacological methods such as surgery. So US ODD may be the first step.
Together with our strategic experts within the RegSmart team we will support you with your application for ODD in EU as well as in US. We write, guide, coordinate, and submit, making sure all the regulatory requirements are met.
Interested in ODD? – contact firstname.lastname@example.org