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.
Policies:
- Review of FDA Regulated Research Policy
- This document describes the policy the Health Sciences IRBs follow for conducting reviews of applications that fall under FDA regulations.
- 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.
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- This document describes the policy the Health Sciences IRB follows for the emergency use of test articles and the emergency use of Humanitarian Use Devices (HUDs).
- Humanitarian Use Device Policy
- This document describes the policies the Health Sciences IRB follows for conducting reviews of applications involving Humanitarian Use Devices (HUDs).
- 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
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.