Adverse Event Reporting System

Apr 24, 2020

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for 'Off-Label' Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

Mar 04, 2020

FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

Nov 01, 2019

Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs

Oct 29, 2019

Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts

Jul 22, 2019

FDA In Brief: FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products

Apr 03, 2019

FDA takes new steps to increase access to adverse event report data for medical products used in animals

Feb 27, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

Jan 09, 2019

The Future of FDA's Electronic Safety Surveillance

Sep 28, 2017

FDA improves access to reports of adverse drug reactions