UW Research
Emergency Use, Drug or Biologic Notification
This document is used by physicians to:
- 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;
- Guide them through the procedures required by the FDA and the UW for emergency use; and
- Notify the IRB of the emergency use with in 5 business days after the use.
Change Notes
Add steps for Billing Compliance and OSP Expanded Access Agreements – 03.27.2025
Updates Fred Hutch email addresses from @scca.org to @fredhutch.org – 03.28.2024
Updated email address to hsdreprt for requests for manufacturer letters; other updates to instructions – 02.01.2024
Add Fred Hutch Cellular Therapy Laboratory contact and procedural info – 04.27.2023
Shift all HSD staff responsibilities to Regulatory Affairs team – 01.26.2023