Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices." The draft guidance provides recommendations to help clinical investigators comply with the safety reporting requirements of investigational new drug application (IND) studies and investigational device exemption (IDE) studies. The guidance is intended to help clinical investigators of drugs identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) and to help clinical investigators of devices identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and to IRBs.