Adverse Event Reporting – Regulations and Best Practices to be Followed

• By: Staff Editor
• Date: October 06, 2011

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.