1 results match your criteria: "University of Sidney Charles Perkins Center and School of Pharmacy[Affiliation]"
US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS).
Pharmaceut Med
April 2020
Faculty of Medicine and Health, University of Sidney Charles Perkins Center and School of Pharmacy, Sydney, Australia.
Background: The US Food and Drug Administration (FDA) and other major regulators regularly issue safety advisories about licensed drugs with new adverse effects that have been documented through observational studies, clinical trials, and spontaneously reported adverse drug events.
Objective: To assess the possible effects of a representative group of FDA Drug Safety Communications on the reporting of the specific adverse effect featured in the advisory on new cases reported to the FDA Adverse Event Reporting System (FAERS).
Methods: We examined 16 FDA Drug Safety Communications issued from 2010 to 2015 that had not previously been the focus of advisories from regulators in the UK, Canada, or Australia.