PDR Network introduces RxEvent, a new online network to collect and distribute adverse drug events now available to all US prescribers via integration into electronic health record platforms and other online services, including directly at www.RxEvent.org.
Roughly half a million adverse drug events are reported annually to the FDA, with over 90 percent of these reports coming from pharmaceutical manufacturers who receive them from physicians and other providers via telephone. This legacy call center-based system is expensive for manufacturers and inconvenient and time-consuming by physicians; it is not surprising that studies show as few as one in ten ADEs are actually reported by healthcare professionals due to this cumbersome process. RxEvent addresses this issue by offering physicians a new way to report ADEs quickly and easily from within their workflow to improve the quality, timeliness, and overall reporting of adverse events.
RxEvent benefits include:
· Decreasing costs associated with current call centers and backend manual processing and reporting;
· Improving reporting quality and rates by physicians and pharmacists by placing the system within their workflow;
· Increasing data mining value through report customization and electronic data gathering; and
· Allowing for monitoring of off-label use and new side effects developing with approved use.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.