Index of FDA Requirements & Guidance

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)