Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications

March 14, 2024 11:00am

Jennifer L. Bragg
Skadden, Arps, Slate, Meagher & Flom LLP

John D.W. Partridge
Gibson, Dunn & Crutcher LLP

  • Clarifying FDA’s current position on First Amendment and off-label promotion
    • The 21st Century Cures Act
    • FDAMA 114
  • What to expect concerning proposed legislation, rules changes and Citizen Petitions
  • Cases and controversies: state AG actions and private tort claims