Forms and Templates

Emergency Use, Drug or Biologic Notification

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This document 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 for emergency use; and
3. Notify the IRB of the emergency use with in 5 business days after the use.

Change Notes

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
Retitle; transfer content from PDF to Word; moderate reorganization and revision to content; add FHCC as a site for emergency use applications – 08.25.2022