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 ...

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

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

The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

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, ...

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 ...

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 ...

The FDA Adverse Event Reporting System (FAERS) contains reports from health care professionals, consumers, and manufacturers on adverse events, serious medication errors, and product quality ...

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.

To increase transparency, the agency is publishing data from the FDA Adverse Event Reporting System daily rather than quarterly. (HealthDay News) — The U.S. Food and Drug Administration is now ...