Medical College of Wisconsin - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

MCW Office of Research Standard Operating ProcedureOpens in new window

“When a patient has a serious or life-threatening condition that is not addressed by current approved treatments, options may exist to use an investigational device (i.e. one that has not been approved or cleared by FDA) to treat the patient. A variety of FDA mechanisms exist to grant this expanded access, including: Compassionate Use (or Individual Patient/ Small Group Access) Treatment Investigational Device Exemption (IDE)”

EAP Related Articles from Sponsor

Score contribution: 80 — 4 supporting sources.

Score 804 references

Featured Reference

IRB Committee Member Procedures and Guidelines | Human ...Opens in new window

Emergency or Expanded Access Submissions [Emergency Use of Investigational Drugs, Devices or Biologics](https://www.mcw.edu/-/media/MCW/Departments/Human-Research-Protection-Program/IRB-Members/IRB-Member-SOPs/IRB-Member-SOP-Emergency-Use-FINAL.pdf) (PDF) [Expanded Access Use of an Investigational Drugs and Biologics](https://www.mcw.edu/-/media/MCW/Departments/Human-Research-Protection-Program/IRB-Members/IRB-Member-SOPs/IRB-Member-SOP-Expanded-Access-Use-FINAL.pdf)(PDF) [Expanded Access Use of Investigational Device](https://www.mcw.edu/-/media/MCW/Departments/Human-Research-Protection-Program/IRB-Members/IRB-Member-SOPs/IRB-Member-SOP-Expanded-Access-Use---Devices.pdf) (PDF)

IND & IDE Support | Toolboxes | Research Training | Medical ...Source

All MCW-sponsored regulatory submissions to the FDA must be reviewed by the Research Oversight Program prior to submission to FDA, excluding expanded access and emergency use requests.

Research | Infectious Diseases | Medical College of WisconsinSource

She has been the site PI on several clinical trials focusing on COVID therapeutics including Gilead – Remdesivir Expanded Access Program (Site PI); Merck – Phase 2/3 Molnupiravir in outpatients with COVID (Site PI), and the FDA expanded access program for convalescent plasma in the treatment of patients with COVID-19.

MCW Office of Research Standard Operating ProcedureSource

a. The following IRB submissions and activities may be “approved” by the IRB and cite “IRB Approval Date” and/or “IRB Expiration Date” i. Initial Application: except in cases where the review has been determined to meet exemption criteria, qualify for FLEX review or not human subjects research. ii. Amendments: these documents will only include an IRB approval date. If the amendment includes a revised consent form, the consent form will receive an effective date. iii. Continuing Progress Reports (CPR) iv. Expanded Access of an investigational drug, device or biologic v. Humanitarian Use Devices vi. Final or Completed Continuing Progress Reports (CPR)

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