The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to transform raw data into usable information. It's been eight months since FDA launched one of these tools--the FDA Adverse Event Reporting System (FAERS) Public Dashboard. In this issue, the architects of the FAERS Public Dashboard – Deputy Director of the Regulatory Science Staff Suranjan De, and Acting Team Lead in Regulatory Science Information Sanjay Sahoo—both of CDER’s Office of Surveillance and Epidemiology, highlight their work with this new online tool.
Q: What is the FAERS Public Dashboard?
A: FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA regarding drugs and therapeutic biologics. These reports are submitted voluntarily by the public via the MedWatch Program, and are required to be submitted by the pharmaceutical industry. The FAERS Public Dashboard is specifically designed for the public to access and view FAERS data in a customizable, searchable format. It allows users to view a summary of adverse event reports received from 1968 to the present or for a specific timeframe