Scientific Publications by FDA Staff

Clin Pharmacol Ther 2014 May;95(5):496-8

Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics.

Fang H, Su Z, Wang Y, Miller A, Liu Z, Howard P, Tong W, Lin SM

The FDA Adverse Event Reporting System (FAERS) is a database for post-marketing drug safety monitoring and influences FDA safety guidance documents, such as changes in drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standard and thus has become an important resource for regulatory science. While the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics.Clinical Pharmacology & Therapeutics (2014); Accepted article preview online 21 January 2014; doi:10.1038/clpt.2014.17.