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In the US, the FDA (Food and Drug Administration) approves new medical devices. The CMS (Centers for Medicare & Medicaid Services) decides whether to cover…
On Restoring the Credibility of the FDA: Personal Observations
The ill-advised FDA decision to shamelessly endorse an unproven treatment for COVID-19 on national TV as a ‘historic breakthrough’ is wrong on so many counts…
In the Eye of the COVID-19 Storm
Editor’s note: James Stein has been writing a series of posts on Facebook on the COVID-19 crisis, providing a sensible overview of current events for nonprofessionals…
FDA’s Gottlieb Preparing To Lower The Bar To Approval
–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it…
Barely Half of Postmarket Studies Completed After 5 Years
–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…
Cardiac Stem Cell Therapies May Get Boost From New FDA
–The FDA may not require companies to prove that stem cell therapies are safe and effective prior to approval. Cardiac stem cell therapy could gain…
No One Knows What’s Actually In Red Yeast Rice Supplements
–Despite tighter FDA rules red yeast supplements may not contain the active ingredient– or far too much of it. A new study offers fresh evidence…
New Stroke Prevention Device May Not Prevent Strokes
–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product…
Abbott Pulls Troubled Absorb Stent From European Market
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be…
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other…