Fixing FDA’s FAERS

Last week FDA announced a new searchable format for its adverse events reporting database, making it easier for drug developers to use the tool to de-risk drug candidates. But according to an August publication from Novartis AG and UCSF, the database needs some scrubbing before it can live up to its promise.

The FDA Adverse Event Reporting System (FAERS) was created to collect information on adverse events that arise outside of the carefully controlled settings of clinical trials after a drug has made it onto the market, including low frequency AEs and those caused by combinations of therapies not tested in the clinic. ...