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(Reuters Health)—Many high-risk therapeutic devices get U.S. Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk…
Institute of Medicine Recommends Changes in Graduate Medical Education
Questions, concerns and spirited debate have surrounded the Graduate Medical Education (GME) system for decades. The program that trains nearly 120,000 physicians per year is under constant scrutiny.1 Changes to the political landscape, combined with ongoing efforts by health industry payers and regulators to squeeze inefficiency out of the system, have kept the GME in…
Many Medical Devices Hit the Market before Safety Studies Are Published
(Reuters Health)—Medical devices approved by the U.S. Food and Drug Administration (FDA) are often cleared before studies on their safety or effectiveness have been released to the public, a report suggests. Without published data, doctors and patients may not be able to make informed decisions about whether to use the products, the authors warn. ad…