USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to FAERS

The US Food and Drug Administration (FDA) has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety reports (ICSRs) for serious adverse events from bioavailability (BA)/bioequivalence and (BE) studies that are exempt from investigational new drug (IND) requirements.

These studies can now be reported to FDA’s Adverse Event Reporting System (FAERs) as an alternate path than reporting these events to FDA’s Office of Generic Drugs (OGD) using the Form FDA 3500A.

On 1 April, FDA began accepting electronic submissions of IND-exempt BA/BE study ICSRs in the electronic format specified in the ICH E2B(R3) standard…