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.
- Review of FDA Regulated Research Policy
- This policy applies to how the Minimal Risk and Health Sciences IRBs apply FDA regulations to human subjects research.
- Control of Test Articles Used in Research Policy
- This policy applies to how FDA regulations are applied to the control of test articles in human subjects research.
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- This policy applies to the emergency use of a test article and the emergency use of Humanitarian Use Devices (HUDs) at the University of Wisconsin - Madison.
- Humanitarian Use Device Policy
- This policy applies to the review of HUDs by the Health Sciences IRB.
- Guidance on Requirements by the FDA for the Investigator as a Sponsor
- Guidance on FDA Regulation of Medical Mobile Apps
- Investigational Software Guidance
- Guidance on Emergency, Expanded Access for an Investigational Medical Product (One Patient)
- Reporting Requirements for Studies Involving Investigational Devices
- Reporting Requirements for Studies Involving Other Investigational Agents, Including Investigational Drugs
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.