The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final ...

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).

The FDA recently sent a warning letter to Novo Nordisk, raising concerns about the drug company failing to report adverse drug events. The letter, dated March 5, outlines the FDA’s observations at the ...

Consolidating adverse event databases is a smart move, but without public education, real-time transparency risks becoming real-time misinformation.

The number of reportable adverse health events in Minnesota hospitals in 2022 increased by more than 12 percent from the year prior, according to data released Sept. 27 by the state’s Department of ...

Per federal regulations, University and affiliate researchers must notify the IRB of unanticipated problems that involve risks to participants or others (henceforth referenced as Unanticipated ...

The number of reportable adverse events in Minnesota hospitals increased from 2010-2011, with the greatest portion of events attributable to pressure ulcers and wrong procedures, according to a report ...