Data Mining and Applications for Pharmacovigilance


Katie Elizabeth Brochu, Nicholas Anthony Diaz, Sadie Grace Gauthier, Erik I. Nadel


Food and Drug Administration


Fred J. Looft, Brigitte Servatius


October – December 2015

Project Outcomes

Final Report


In order to ensure the safety and efficacy of post-market pharmaceutical products, the United States Food and Drug Administration relies on its pharmacovigilance efforts and input from the general public. The FDA receives submissions of adverse event reports from patients, health care practitioners and manufacturers. The FDA has started looking to the field of data mining to automate the search for safety signals. A training manual was created to introduce FDA employees to the concepts and applications of data mining techniques in pharmacovigilance.