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FDA launches new adverse event look-up tool

WASHINGTON - The Food and Drug Administration has launched what it is describing as a "unified dashboard" for identifying and ...
Healio

Transparency or ‘unnecessary alarm’? Explaining FDA’s reporting tool for cosmetic harms

Please provide your email address to receive an email when new articles are posted on . The FDA launched a new online dashboard for reporting adverse events related to cosmetic products. This ...
Becker's Hospital Review

The AI Adverse Event Problem Nobody Is Talking About

The AI adverse event problem nobody is talking about reveals risks in FDA-cleared surgical devices lacking robust clinical trials.
Pharmaceutical Commerce

FDA Vowes Improved Adverse Event Reporting With AEMS

The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.
Yahoo

FDA to provide daily updates on adverse events

Add Yahoo as a preferred source to see more of our stories on Google. The FDA announced it will now update its Adverse Event Reporting System every day, instead of once per quarter. Photo courtesy FDA ...
Fierce Pharma

Novo Nordisk's US headquarters under fire in latest FDA warning letter

Amid the company’s efforts to resolve issues raised during an FDA inspection early last year, Novo Nordisk’s operating base in Plainsboro, New Jersey—already the recipient of a recent Form 483—has ...
MedPage Today

Goodbye FAERS? FDA Launches New Combined Adverse Event Database

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...
JD Supra

FDA Launches Public Adverse Event Reporting System for Cosmetic Products

Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS).
Medscape

Adverse Events Post-Colonoscopy Rise With Age but Are Rare

Although adverse event rates within 30 days after surveillance colonoscopy increase with age, peaking among patients aged 76-85 years, they remain infrequent, occurring in < 1% of procedures.
Nature

Drug Safety and Adverse Event Analysis in Clinical Trials

The evaluation of drug safety in clinical trials is a critical element of the drug development process, ensuring that therapeutic benefits outweigh potential harms. Clinical trials, particularly in ...
Hosted on MSN

Statin adverse event labels may be overcautious, analysis suggests

Many adverse events listed on statin product labels don't have good evidence that they are actually caused by the drug, a pooled analysis of the clinical trial evidence showed. In individual ...
UPI

FDA to provide daily updates on adverse events

The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system. In an effort to modernize and provide transparency on ...