USA – FDA shifts IND safety reporting over to FAERS in finalized guidance

The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events to FDA’s Adverse Event Reporting System (FAERS). Currently, these reports are submitted in electronic common technical document (eCTD) format using PDF files.

FDA called the current practice “inefficient and labor intensive” to review and track. These reports are submitted to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

FDA added that it will accept the IND safety reports submitted to FAERS before the effective date.

This guidance finalizes a draft guidance issued in October 2019. (RELATED: FDA to Require Certain IND Safety Reports to be Submitted to FAERSRegulatory Focus 29 October 2019)…