UC Comment Letters

This comment letter responds to the Food and Drug Administration (FDA)'s guidance document, Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices. The University of California (UC) expresses concern that the guidance appears to require investigators to report all IND safety reports and certain serious adverse events to Institutional Review Boards (IRBs) as unanticipated problems. UC recommends that FDA clarify that only safety reports meeting the established criteria for an unanticipated problem should be submitted to IRBs, preserving a risk-based approach that focuses oversight on actionable safety concerns and avoids overwhelming investigators and IRBs with excessive reporting.