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Risks and patients: Should FDA and industry close the perception gap?
When patients can see you, but can't hear you As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the...
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FDA whistleblowers sue FDA: A big deal?
Seriously, what's the big deal? Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to...
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FDA advisory committees: Is there a problem?
I’ve attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It’s true I’m no expert, but recent hearings for medical devices have...
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TAVR: What it says about FDA and CMS
Doctors: the third leg of the PMA approval process? The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it’s time to project into the future. Before we head...
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Is the U.S. no longer the dominant player in med-tech?
In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current...
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The future of device regulations: the EU model or the FDA approach?
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than...
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FDA misconduct not deemed newsworthy
By Kelly Roman, Vice President of Fisher Wallace Labs On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite...
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Bull in a China shop: Jeff Shuren at CDRH
The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been...
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Statistical tinkering in device regulation a disservice to patients
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures –...
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Thank you government!
Guy Fawkes night; a different kind of giving of thanks November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about....
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