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
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