Forms and Templates

Non-Emergency Expanded Access Use, Drug or Biologic Notification

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This form is used by physicians to: (1) determine and document whether the circumstances in which they hope to make emergency clinical use of an investigational drug or biologic meets the FDA requirements for emergency use; (2) guide them through the procedures required by the FDA and the UW, and Fred Hutchinson Cancer Center (Fred Hutch) if applicable, for emergency use; and (3) notify the IRB of the emergency use within 5 business days after the use.

Change Notes

New application for Non-Emergency Expanded Access Use, Drug or Biologic – 03.27.2025