Serious and Unexpected Suspected Adverse Reaction (SUSAR)

An Adverse Event (AE) that meets the definitions of Serious Adverse Event (SAE), unexpected adverse event, and suspected adverse reaction. The sponsor must report a SUSAR in an IND safety report to the FDA within 15 days from initial receipt of the information. Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and, therefore, must be reported to FDA no later than 7 calendar days after the sponsor’s initial receipt of the information. FDA: 21 CFR 312.32, IND Safety Reporting; FDA: Safety Reporting Requirements for INDs and BA/BE Studies