USA – Guidance : Providing Regulatory Submissions in Electronic Format – IND Safety Reports

1. Introduction

1.1 Background

This Technical Conformance Guide (Guide) provides specifications, recommendations, and
general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019), which implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain IND safety reports submitted to CDER or CBER.

1.2 Purpose

This Guide discusses the format for the submission of IND safety reports as required under 21 CFR 312.32(c)(1)(i) as individual case safety reports (ICSRs) to the FDA Adverse Event
Reporting System (FAERS). It provides general information for sponsors of commercial and
noncommercial INDs pertaining to electronic submission of IND safety reports and attachments in electronic format to FAERS. It also provides information to sponsors on the format for submission of IND safety reports required under 312.32(c)(1) that should not be submitted to FAERS and should continue to be submitted in electronic common technical document (eCTD) format…