The three U.S. FDA-regulated categories for accessing unapproved treatments:

  • Individual Patient Access: For a single patient with a serious condition, including emergency situations
  • Intermediate-size Access: For a small group of patients seeking the same unapproved treatment
  • Treatment Protocol Access: For large-scale access to a treatment that’s already being developed for market approval

Sponsor

Collaborator

Source

Expanded access statusFDAAA 801 Violations