VATIS UPDATE Article

The US Food and Drug Administration (FDA) has launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

“Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA,” said Scott Gottlieb, at FDA. The dashboard enables users to search and organize data by criteria such as drug/biological product, age of the patient, type and year of adverse event, or within a specific timeframe.

In addition to making it easier for consumers to search for adverse events reported with drug or biologic products, the FDA hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health care professionals and others, by making it easier for people to see other reports that the FDA receives, and search the database for similar observations.