1. CBER eVAERS Best Practices
  2. Introduction

1 Introduction

This document provides the best practices and recommendations to configure Combination Products and generate PMSR reports for Combination and Non-Combination Products using the eVAERS profile.

FDA has published draft Technical Specification document for Preparing and Submitting Electronic ICSRs and ICSR Attachments in May 2019.

As per FDA, Combination Product Applicants should submit PMSRs using the Vaccine Adverse Event Reporting System (VAERS) consistent with the requirements of the combination product with January 31, 2021 as compliance date.