Safety Assessment for Investigational New Drug Application Safety Reporting; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Safety Assessment for IND Safety Reporting.'' The draft guidance provides recommendations to sponsors on developing a systematic approach to investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND. This draft guidance is a follow-on to the guidance for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/ BE Studies'' that provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators, including a recommendation that sponsors develop a safety assessment committee.