Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form. The specifications apply to electronic submission of ICSRs for drug and biological products, studied under an investigational new drug application (IND); ICSRs from bioavailability/bioequivalence (BA/BE) studies conducted without an IND, and ICSRs for marketed drug and biological products and combination products to the FDA Adverse Event Reporting System (FAERS). The specifications do not apply to the following marketed biological products: prophylactic vaccines, whole blood or components of whole blood, human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated by FDA.