Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards - Final Guidance

Sajan Pandya, a Regulatory Affairs Specialist at Encore Medical Inc., supports the final guidance but argues it lacks a systematic framework for managing the investigator lifecycle to ensure sustained compliance. The commenter proposes that the FDA consider a companion guidance or appendix that addresses operational infrastructure, such as structured onboarding, ongoing training, and performance monitoring.

The University of California system argues that the proposed guidance incorrectly equates all IND safety reports with "unanticipated problems" requiring IRB reporting. They request that the FDA restore a risk-based filtering approach to prevent IRBs from being overwhelmed by high volumes of non-actionable safety information.

The commenters, representing former OHRP leadership and consulting firms, support the FDA's goal of improving safety reporting quality but argue that the current guidance could increase administrative burdens. They suggest specific revisions to clarify "immediate" reporting timelines, frame investigator causality as preliminary clinical judgment, and preserve core concepts from the 2009 IRB guidance to prevent excessive reporting.

The commenter is seeking clarification on whether the proposed guidance requires all IND safety reports to be reported to Institutional Review Boards (IRBs). They note that the current guidance requires a determination of whether a Suspected Unexpected Serious Adverse Reaction (SUSAR) constitutes an Unanticipated Problem (UP), and they are concerned about the potential impact of reverting to reporting all reports.