Getting the ODD: The Art of Orphan Subsetting

Why is the term ‘orphan subsetting‘ important for you to understand, and how does it affect your Orphan Drug Designation (ODD) application? This important consideration can make the difference in whether your ODD is approved. Let’s break it down.

Fundamental Concept: Know Your Audience!

The FDA Office of Orphan Products Development (OOPD), the EMA Committee for Orphan Medicinal Products (COMP), and your FDA review division are unique entities with individual characteristics. Care should be taken to ensure any submissions are written with your particular audience in mind.