Physician's WeeklyOpinion

Strengthening Pharmacovigilance From the Inside Out

Modern pharmacovigilance relies on a network of reporting systems. Regulatory agencies worldwide maintain large databases ...
RAPS

FDA consolidates adverse events reporting systems

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...
FiercePharma

FDA rolls out daily updates to adverse event dashboard, plans to further 'streamline' system

As Department of Health and Human Services (HHS) and FDA leadership continue to look for ways to boost transparency and reshape the U.S' healthcare infrastructure, the U.S. drug regulator has unveiled ...
Healio

FDA begins daily reporting of adverse event data

Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...
JD Supra

DOJ Targets Failure to Report Adverse Events: Lessons From the ExThera Enforcement Action

In March 2026, the US Department of Justice (DOJ) announced criminal charges against medical device company ExThera Medical Corporation and its ...
The Daily Signal

Restoring Trust in Public Health: Transparency Urgently Needed in Reporting Adverse Vaccine Effects

This is the final piece in an eight-article series on “Restoring Trust in Public Health: Lessons from COVID-19.” Four years of the Biden-Harris administration has left Americans rightly skeptical of ...