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The FDA’s long-awaited revision of Part 11, which is now slated for release this year, will impose major new burdens on industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.
A recently published clinical study suggests that a drug-coated balloon treatment may be a viable alternative to stenting to counter recurrent in-stent restenosis — the renarrowing of a coronary artery after stent surgery to expand it.
Industry experts speaking at an FDA public hearing voiced their support for the agency's all-electronic submission system proposal, but warned that the agency has a lot to consider before going forward.
Clinical research information should be included in the Nationwide Health Information Network (NHIN) to enable faster discovery and assessment of cures and treatments, according to a report from nonprofit FasterCures.
As information technology (IT) becomes integral in medical device design, clinical and IT specialists need better communication during the earliest stages of device development, experts said at a
recent audioconference hosted by healthcare research group ECRI.
Devicemakers need to design products that will work in the high-tech hospital environment of the future, experts said at a conference last month. Read More
Electronic interactive voice response (IVR) and interactive web response (IWR) systems are recommended for drug accountability during a clinical trial, according to two experts speaking at a recent FDAnews audioconference. Read More
After cataloging shortcomings in its adverse event review process for devices and combination products, Medtronic said it decided to establish a centralized review group to develop a more efficient reporting system.
Using the “lab model” standard developed by the Clinical Data Interchange Standards Consortium (CDISC) can help clinical trial sponsors transmit large laboratory data sets more efficiently, according to Bob Lyons of Nextrials, who was speaking at a recent CDISC conference.