Tweeted by @TomBurtonWSJ
Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?
Most products get to market via a fast-track process; three experts debate whether the current system makes sense
http://www.wsj.com/articles/do-the-fdas-regulations-of-medical-devices-need-to-be-overhauled-1427079649The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.
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Tweeted by @JohnsHopkinsSPH
"Action and Dysfunction in the U.S. Food-Safety Effort"
http://www.nytimes.com/2015/05/11/us/action-and-dysfunction-in-the-us-food-safety-effort.html?_r=2Dr. Acheson, for one, says that nothing short of a catastrophe may be necessary to rattle officialdom sufficiently to redesign the safety system. Rather grimly, he told Retro Report, “We need — I hate to say it, but — bodies in the street before we get it.”
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Tweeted by @ElaineSchattner
"An FDA panel just backed the "female Viagra." Critics say it's a mistake."
http://www.vox.com/2015/6/4/8732723/female-viagra-fdaAlthough the evidence hasn't improved since the FDA's last rejection of flibanserin in 2013, the marketing push around the drug has gained traction: Sprout put together the "Even the Score" campaign accusing the FDA of being sexist for not getting the pink pill on the market to help women.
the panel was convinced by the many women who had been brought there by Sprout to talk about the tragedy of their low libido