Assessing Evidence of Efficacy and Safety for New Drug and Device Approvals

Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study (Published in The BMJ, October 2022) – Meera Dhodapkar, Xiaoting Shi, Reshma Ramachandran, Evan M. Chen, Joshua D. Wallach, Joseph S. Ross

• The authors characterized potential drug safety signals identified from the FDA Adverse Event Reporting System (FAERS) from 2008 and 2019 to determine how frequently these signals led to a regulatory action by the FDA and whether these actions were corroborated by the medical literature or public assessments by the Sentinel Initiative. They found that while most potential safety signals from FAERS led to regulatory action by the FDA, only a third of these actions were supported by published research and none by Sentinel Initiative public assessments.
• Accompanying Opinion in The BMJ (10/5/2022): Spontaneous reporting of post-market safety signals: what evidence should support regulatory action?