New Data-Driven Approaches Would Improve How FDA Monitors Safety of Approved Drugs
New research in the INFORMS journal Management Science finds that the U.S. Food and Drug Administration (FDA) could enhance public safety by employing new data-driven approaches to identify adverse effects of drugs faster and more reliably, which would improve the regulatory decision-making and oversight processes. This approach would substantially contrast with the current FDA approaches for monitoring drug safety, which suffers major drawbacks (e.g., they are based on voluntary reports that can result in inaccurate or untimely decisions).