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Devicemakers have expressed concern about cost-containment initiatives by the Centers for Medicare & Medicaid (CMS), and are thought by some experts to be resistant to long-term solutions to controlling healthcare costs.
A new, more active adverse event reporting system involving insurance data mining, further analysis of electronic medical records and population-based databases is necessary to ensure drug safety, researchers say.
Researchers are proposing an alternative to Cox-2 inhibitors that lack the cardiovascular risks associated with those drugs and have discovered why those painkillers allegedly trigger heart problems in some patients, according to an article published April 13.
Electronic medical databases will provide a more effective means of reporting adverse events, playing a major role in improving drug safety, leading agency and industry sources say.
The FDA released guidance April 19 to assist applicants with electronic submissions to the agency using the electronic common technical document (eCTD) specifications.
Clinical trial data must be collected and recorded electronically into both the medical record and clinical research databases through a single process to achieve maximum benefit, Phase Forward founder and chairman Paul Bleicher told CTA.
New, real-time treatments will improve patient outcomes for prostate cancer and help lower the time and expense of more traditional radiation therapies, according to companies that have recently developed devices to enhance brachytherapy for prostate cancer.