University of Utah IRB indexes for FDA requirements and guidance do not reflect all of the available guidance and resources published by the FDA. The University of Utah IRB has complied the indexes with commonly used information from the FDA. Consult www.fda.gov for additional information about FDA requirements and guidance.
Drugs & Biologics |
Index for Investigational Drugs & Biologics (UU Guidance with Additional FDA References) Expanded Access to Investigational Drugs (UU Guidance with Additional FDA References) Emergency Use of a Test Article (Drugs/Devices) (UU Guidance with Additional FDA References) |
Devices |
Index for Investigational Devices (UU Guidance with Additional FDA References) Expanded Access Mechanisms for Unapproved Devices (UU Guidance with Additional FDA References) Emergency Use of a Test Article (Drugs/Devices) (UU Guidance with Additional FDA References) |
Informed Consent |
Planned Emergency Research (UU Guidance with Additional FDA References) |
Participant Considerations |
Withdrawing from Clinical Trials (UU Guidance) |
FDA Submission Process |
Preparation Packet for Investigator-Initiated Drug and Device Studies (UU Guidance with Additional FDA References) |