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.
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.
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.