The New York State Department of Health offers a free, downloadable adverse event reporting form for office-based surgery. The four-page form includes sections detailing accreditation, the nature of ...

The Medical Board of California implemented a new set of adverse event reporting procedures, effective Jan. 1, for accredited outpatient surgery facilities. 1. The current law requires outpatient ...

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...

Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...

Doctors at the University of Minnesota Medical Center left more foreign objects in their patients during surgery last year than they did the year before, according to state data. Adverse Health Events ...

When the HSRO approves human-subjects research, the approval is based upon the information about how the research will be conducted and the risks and anticipated benefits to subjects that are known at ...

What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December. Who’s Impacted: Cosmetic product manufacturers. What Should You Do: Companies should stay up to ...

A new report adds the Inspector General’s voice to the autopsy of America’s recent infant formula shortage. The Inspector General’s Office for the U.S. Department of Health and Human Services has ...

The Union health ministry has asked the adverse drug reaction monitoring centres (AMCs) across the country to report serious adverse events during the course of usage of a medical devices as part of ...

A team at Cincinnati Children's Hospital Medical Center has created a tool to improve analysis of adverse event data gathered by FDA. The web-based system, AERSMine, is designed to make it easier to ...

VAERS stands for the Vaccine Adverse Event Reporting System. It’s a nationwide early warning system that helps the CDC and FDA spot possible safety problems with vaccines licensed in the U.S. The ...