–FDA fails to enforce requirements. Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows. The topic has gained increasing visibility and importance as the FDA has…
The Impact Of ABSORB II: Down The Slippery Slope
November 2, 2016 by 2 Comments
When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…
Report Finds Problems With FDA Mandated Postapproval Device Studies
November 16, 2015 by Leave a Comment
As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…
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