FOCUS ON FDA

GDUFA III User Fees, Guidances, and MAPPs – User Fee Reauthorization Riders and New Litigation with FDA

April 20, 2023 8:15am

Christopher Pruitt
Deputy Director, Office of Generic Policy
U.S. FDA

Brian Stone
Associate General Counsel
Global Legal-Regulatory
Viatris

Maryll W. Toufanian
Senior Vice President, Regulatory Strategy and Policy
Amneal Pharmaceuticals

Moderator:

David B. Abramowitz
Partner
Locke Lord LLP

  • Examining the areas of focus in GDUFA III
    • Complex drugs
    • Facility inspections and re-inspections
    • Understanding the GDUFA III commitment letter
  • Analyzing user fee reauthorization riders
  • Taking stock of recent litigations with FDA
    • Avadel v. FDA
    • Melinta v. FDA