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

摘要

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices." The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. As such, recommendations are provided in this guidance to help investigators identify safety information that needs to be reported to sponsors and IRBs. This guidance finalizes the draft guidance of the same title issued on September 30, 2021.