FDA Lifecycle Management Webinar Series: Orphan Drug Designation and Exclusivity

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