FDA Regulated Research Policies and Guidance

The following policies and guidance documents are intended for researchers working with drugs, devices, and biologics regulated by the US Food and Drug Administration (FDA).  The policies and guidance are meant to assist researchers with ensuring compliance with both FDA regulations and institutional requirements.

Health Sciences IRBs Policies and Guidance

The UW-Madison Health Sciences IRBs review all human subject research protocols in accordance with applicable federal regulations, including FDA regulations.  The following documents represent the HS IRBs policies and procedures for the review of FDA regulated research submissions.


  • Control of Test Articles Used in Research Policy
    • This document describes the policy researchers must follow regarding the control of test articles that fall under FDA regulations and how the Health Sciences IRBs assess the control of test articles used in research.
  • Humanitarian Use Device Policy
    • This document describes the policies the Health Sciences IRB follows for conducting reviews of applications involving Humanitarian Use Devices (HUDs).
Additional Guidance:

FDA Regulated Research Oversight Program Overview

The FDA Regulated Research Oversight Program is charged with drafting policies and establishing guidance for UW-Madison researchers conducting FDA regulated research.  In addition, the Oversight Program registers and tracks investigator held INDs and IDEs, performs routine audits of all FDA regulated research studies to verify investigator compliance with FDA requirements, and ensures timely and appropriate communications with the FDA.

FDA Regulated Research Oversight Program Polices, Guidance, and Resources can be found here.

Keywords:FDA, Food and Drug Administration, Food, Drug, Drugs, Biologics, Humanitarian, Device, Devices, IND, IDE, INDs, IDEs, IND/IDE, Audits, Compliance, Sponsor, Sponsor-investigator, sponsor investigator, Mobile, One-time, Onetime, One time, Agents, Emergency, Oversight, FDA regulated   Doc ID:85088
Owner:Monica E.Group:Health Sciences IRBs
Created:2018-08-21 14:42 CDTUpdated:2020-03-19 05:31 CDT
Sites:Health Sciences IRBs
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