**INTRODUCTION **
This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS) database. 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.
BACKGROUND
In the Federal Register of September 29, 2010, FDA published a final rule that revised the IND (including Bio-IND) safety reporting requirements for human drug and biological products under 21 CFR part 312. It added safety reporting requirements for persons conducting IND-exempt BA/BE studies under 21 CFR 320.31. This regulation outlines when BA and BE studies are exempt from the IND requirements. The exemption from IND requirements may apply to studies conducted to support abbreviated new drug applications (ANDAs) and other drug applications.
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 the drug product can be expected to have the same therapeutic effect as the listed product, adverse events 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 an ANDA or NDA submission, as appropriate based on the purpose of the BA/BE study.
In the past, expedited safety reports from IND-exempt BA/BE studies have been submitted to the Office of Generic Drugs (OGD) by email, telephone, or facsimile using the Form FDA 3500A. However, enhancements to FAERS will allow electronic submission of ICSRs from IND-exempt BA/BE studies. This guidance provides recommendations on how to electronically submit ICSRs to the FAERS database as an alternate avenue for submitting reports to OGD once these enhancements are activated.
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