Guidance Regarding Emergency Use and Expanded Access Protocols During a Public Health Emergency
During public health emergencies, it is common for new drugs, biologics, and therapies to be used under Emergency Use and Expanded Access protocols. As the number of cases of monkeypox continues to rise, the VCU HRPP would like to direct investigators to the available guidance on Emergency Use and Expanded Access protocols.
For guidance on Emergency Use of test articles, view VCU HRPP Written Policy and Procedure (WPP) XVI-3: Emergency Use of a Drug, Device, or Biologic.
For guidance on Expanded Access, see VCU HRPP Written Policy and Procedure (WPP) XVI-5: Expanded Access to Unapproved Drugs, Devices, or Biologics.
Studies proposing to utilize TPOXX for treatment of monkeypox under the expanded access provisions should proceed with the operations laid out by the CDC. A reliance agreement has been executed with the IRB at the CDC for TPOXX protocols specifically. The CDC has further information in their Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Cases.
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