It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status.
- Overview of Breakthrough vs Fast Track vs Accelerated Approval, etc.
- FDA and EMA engagement techniques to keep momentum and enthusiasm even without Breakthrough
- Panel will share success stories and real-world examples of their strategies and FDA / EMA interactions that allowed for regulatory success
- Equally important – what NOT TO DO examples will be shared