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

September 15, 2022 11:00am

Seth A. Mailhot
Husch Blackwell LLP (New York, NY)

  • 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