FDA Issues Final Guidance Clarifying Safety Reporting for Clinical Investigators
December 16, 2025
December 16, 2025
WASHINGTON, Dec. 16 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has made available a final guidance document to clarify safety reporting requirements for clinical investigators.
Titled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices," the guidance aims to help investigators comply with regulations governing investigational studies.
The document provides advice to investigators . . .
Titled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices," the guidance aims to help investigators comply with regulations governing investigational studies.
The document provides advice to investigators . . .