There are three different types of expanded access for drugs/biologics:

• Expanded access for individual patients, including for emergency use
  • If there is not time to obtain IRB approval for the treatment use of an investigational product (drug/biologic, or device), this constitutes an emergency use, and treating teams should follow this guidance: Emergency, Expanded Access for an Investigational Medical Product (One Patient).
• Expanded access for intermediate-size patient groups
  • For use by more than one patient, but generally fewer patients than are treated under a typical treatment IND or protocol
• Expanded access for widespread treatment use
  • Access to an investigational drug (including a biologic) for treatment use by a large (widespread) population under a treatment IND. The investigational product must be under active development for marketing.

See HRP-324 for additional information.