Sponsor Overview
Explore verified public information about VA Office of Research and Development's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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Expanded Access Intelligence
Official Statements
Score contribution: 100 — 6 supporting sources.
“This Institution assures that whenever it provides investigational drugs or biologics or approved drugs that have limited availability due to a REMS to a patient for COVID-19 under an expanded access program, it will comply with FDA regulations at 21 CFR 312 Subpart I, Investigational New Drug Application: Expanded Access to Investigational Drugs for Treatment Use.”
“The Centers for Disease Control and Prevention (CDC) has worked with the VHA Offices of Research and Development (ORD) and the Office of Research Oversight (ORO) on establishing a mechanism for VHA Facilities to rely upon the CDC Institutional Review Board (IRB) to participate in the expanded access program: "Protocol #6402 'Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children' (IND 116039)"”
“On July 25th, 2022 the VA Research Community was notified that ORD would provide instructions regarding the steps required for VA Facilities with research programs to rely upon the CDC IRB, including the VA Facility concurrence form that the VA Facility Director is required to sign formalizing the CDC IRB reliance agreement. Both ORD and the VHA Office of Research Oversight (ORO) have finalized the steps regarding the CDC IRB reliance procedures for VA Facilities with research programs. The document also includes additional information ORD is implementing or in process of implementing to support VA Facilities utilizing this expanded access program.”
“The purpose of this Office of Research & Development (ORD) guidance document is to provide guidance on procedures designed to streamline the use of VA DocuSign with the Centers for Disease Control and Prevention (CDC) Institutional Review Board (IRB)-approved informed consent form and the VA Form 5345 - Request for and Authorization to Release Health Information for VA Facilities conducting the Expanded Access Program (EAP): “Use of Tecovirimat $( \mathsf { T P O X X } \mathsf { R } \odot )$ for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children” (IND 116039/CDC #6402).”
“The Office of Research and Development will present a webinar on expanded access of investigational drugs in VA, including information on the expanded access program for remdesivir.”
“Non-emergency expanded access protocols or activities approved by the IRB. NOTE: Emergency expanded access protocols or activities do not require prospective R&D Committee approval or notification. Single patient expanded access protocols approved by the IRB Chair or another appropriate IRB voting member.”
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