2023年3月16日
FDA Lifecycle Management Webinar Series: Orphan Drug Designation and Exclusivity
Speakers:
Join Mayer Brown FDA regulatory partner George O’Brien and associate Charles Watson for the next installment of our FDA Lifecycle Management webinar series. In this webinar, George and Charles will:
- Provide an overview of the Orphan Drug Act
- Discuss strategies that have proven successful for obtaining orphan drug designation and exclusivity
- Explain the role of “clinical superiority” determinations under the Act
- Unpack real-world examples of FDA’s decision-making precedent
- Cover the ongoing impact of the Eleventh Circuit’s Catalyst decision
- Discuss the application of the Act to innovative product classes, such as cellular and gene therapies
