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 ...

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

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 ...

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 ...

Clinical trials utilize multiple methods of tracking, categorizing, and assessing any side effects at each trial stage. A negative side effect during clinical trials, whether expected as a potential ...

The Journal of Clinical Oncology podcast, hosted by Dr. Davide Soldato, presents analyses and discussions centered on the latest findings published in ASCO’s esteemed Journal of Clinical Oncology.