Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies.”
A safety report documenting a serious adverse event (SAE) experienced by a study subject during the conduct of an IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an electronic format that FDA can process, review, and archive.
This guidance provides instructions for the electronic submission of serious adverse events (SAEs) in expedited individual case safety reports (ICSRs) from the investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS).
An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission.
ICSRs in FAERS include critical information FDA uses during ongoing safety surveillance across the drug life cycle. Submitting ICSRs from IND-exempt BA/BE studies electronically is voluntary.
There will be two options for electronic submission of ICSRs and ICSR attachments to FAERS:
FAERS database-to-database transmission direct submission through the Electronic Submissions Gateway
Submission through the Safety Reporting Portal
FDA is not currently accepting the submission of premarket ICSRs in the E2B(R3) format. This guidance should help generic sponsors who are opting to submit electronic IND-exempt BA/BE safety reports prepare their systems