WASHINGTON - The Food and Drug Administration has launched what it is describing as a "unified dashboard" for identifying and ...

To examine concordance in symptomatic adverse event (AE) grading using the Common Terminology Criteria for Adverse Events (CTCAE 4.0) for clinicians and its patient-reported outcome (PRO) versions for ...

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

The risk of major adverse events during the periprocedural period is roughly fourfold higher with CABG surgery than with PCI for left main coronary artery disease, but regardless of the initial ...

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, ...

Nearly a quarter of stays among an 11-hospital sample of roughly 2,800 admissions included at least one adverse event, and about 7% of admissions included an adverse event that could have been ...

Pregnant women with symptomatic coronavirus disease 2019 (Covid-19) have a higher risk of adverse outcomes than do women who are not pregnant. 1,2 In part because of these findings, Covid-19 ...

Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...

Discovery of immune checkpoint inhibitors has revolutionized the therapeutic landscape for the treatment of cancer. Development of immunotherapy for cancer is based on modulation of T cell function ...

Objective To identify the optimal dose and type of physical activity to improve functional capacity and reduce adverse events in acutely hospitalised older adults. Design Systematic review and ...