Summary
An orphan designation may add value to a product by potentially increasing stock value, increasing the company visibility, and initiating early interactions with Health Authorities. However, seeking an orphan designation too early has its disadvantages, including public disclosure of regulatory strategy, product positioning, and risking a premature application with a following rejection due to insufficient data. As a result, when to submit an ODD is subject to particular consideration. This paper explores how to optimize this process.
Register to download
How to Successfully Navigate Orphan Drug Designation
You may also be interested in:

Global Regulatory Affairs
PRA’s Global Regulatory Affairs (GRA) group brings more than 20 years’ experience navigating the complex regulatory environment. We leverage our…

Regulatory Considerations for Biotech
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
