FDA Lifecycle Management Webinar Series: Orphan Drug Designation and Exclusivity

Join Mayer Brown associate Charles Watson for the next installment of our FDA Lifecycle Management webinar series. In this webinar, 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