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The US Food and Drug Administration on Friday revealed it has begun daily publication of adverse event data from the FDA ...
The FDA will now publish adverse event data from FAERS on a daily basis, marking a major step toward greater transparency in drug development.
A new commission will investigate the prevalence of SSRI antidepressants as adverse event reports document hundreds of cases ...
The US Food and Drug Administration (FDA) announced late last week that it has suspended the license for French drugmaker ...
There have been 4 new reports of serious adverse events related to Ixchiq based on updated Vaccine Adverse Event Reporting System data.
In the current study, a team of researchers at the University of Bern analyzed data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System, a post-marketing, open-access ...
McCall KL, Mastro Dwyer KA, Casey RT, et al. Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system. Expert Opin Drug Saf.
Currently, adverse drug event reporting is voluntary, resulting in probable underreporting and skewed data, according to a report from the Regulatory Affairs Professional Society.
HHS secretary Mike Leavitt said a prescription drug adverse-event reporting system could be one of the first projects that a federal advisory group might take on as part of an initiative to build ...
The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing ...