The Drugs Technical Advisory Board (DTAB) has agreed with a proposal to amend the Medical Devices Rules (MDR), 2017, to include definition of reportable events related to medical devices, in a move to ...

In March 2026, the US Department of Justice (DOJ) announced criminal charges against medical device company ExThera Medical Corporation and its ...

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 ...

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 ...

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.

New service makes adverse event reporting easier and more efficient than ever. The Veterinary Medicines Directorate (VMD) has today launched a new digital service for reporting adverse events ...

The Veterinary Medicines Directorate (VMD) has launched a new digital service for reporting adverse events associated with ...