6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

Last Revised: 1/23/2024

1.0 Purpose


2.0 Policy


3.0 Definitions


4.0 General Considerations


5.0 Investigator procedures


6.0. IRB / ORA procedures



DOCUMENT HISTORY:

 Written: 1/18/2021 (Approved: 1/18/2021) - original author not recorded

 Revised: 1/23/2024 – added information regarding continuing review for expanded access protocols (section 6.6).


Revision #7
Created 27 January 2021 16:03:32 by Autumn M Eberly
Updated 17 April 2025 16:08:39 by Robert A Lewis