Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

FDA released guidance on 01-April-2024, that provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs) to FDA Adverse Event Reporting System (FAERS). The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submitting these required reports.

A safety report documenting a serious adverse event (SAE) experienced by a study subject during 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.

As required by regulation, a safety report documenting a fatal or life-threatening adverse event from the study must be
submitted to FDA as soon as possible but in no case later than 7 calendar days after becoming aware of its occurrence (7-day report). Safety reports documenting other SAEs observed during the conduct of the study must be submitted to FDA as soon as possible but no later than 15 calendar days after becoming aware of the SAE occurrence (15-day report).

The expedited reporting requirements for IND-exempt BA/BE studies apply only to BA/BE studies conducted in the United States. In addition to the requirements for expedited safety reporting described in § 320.31(d), as part of the information required to establish that a proposed drug product intended for submission in an
ANDA pursuant to section 505(j)(2)(C) of the FD&C Act can be expected to have the same therapeutic effect as the listed drug, adverse event information from IND-exempt BA/BE studies, regardless of whether the study is conducted inside or outside of the United States, must be
included in the ANDA.

In the past, expedited safety reports from IND-exempt BA/BE studies have been submitted to the Office of Generic Drugs by email, telephone, or facsimile using the Form FDA 3500A.
However, enhancements to FAERS enable electronic submission of ICSRs from IND-exempt BA/BE studies. This guidance provides recommendations on how to electronically submit ICSRs to FAERS as an alternate avenue for submitting reports to OGD.

Refer the updated guidance document from FDA for details –

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-expedited-safety-reports-ind-exempt-babe-studies-guidance-industry