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 use an investigational drug or biologic for clinical treatment of a single patient meet the FDA requirements for expanded access; (2) guide them through the procedures required by the FDA and the UW, and Fred Hutchinson Cancer Center (Fred Hutch) if applicable; and (3) notify the UW IRB of the proposed single patient expanded access (non-emergency) use for chair concurrence prior to use.

Change Notes

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