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BioWorld - Wednesday, February 11, 2026
Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Washington roundup: FDA posts warning letter to Cook one year after issuance

July 3, 2012
By Mark McCarty

FDA advisory committee: Panel suggests MRI to check on symptomatic MoM patients

July 2, 2012
By Mark McCarty

Washington roundup: Roberts casts deciding vote to uphold Affordable Care Act

June 29, 2012
By Mark McCarty
Chief Justice John Roberts surprised almost the entire nation in voting to uphold the Affordable Care Act after months of speculation that Justice Anthony Kennedy would provide the deciding vote, and the Affordable Care Act is nearly intact going forward. The decision reinforces the most sweeping piece of healthcare legislation since the inception of Medicare in 1965, and sets up a controversial vote in the House of Representatives on legislation to repeal the ACA.
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Counting to 51: The fate of the device tax and the Affordable Care Act

June 28, 2012
By Mark McCarty
The biggest judicial showdown in quite a while is finally over, and here are a couple of things to consider while we’re playing numerology games in an effort to interpret the scribblings of nine citizens in black robes we all now refer to as SCOTUS. I for one can understand why the Supreme Court was unimpressed with the attempt to argue the validity of the Affordable Care Act on the basis of the Commerce Clause. In this decision the Court basically said the government cannot force citizens to participate in commerce, a position that comports with precedent. By the way,...
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FDA advisory committee: Day one of MoM hearing offers more questions than answers

June 28, 2012
By Mark McCarty

Washington roundup: Senate passes S. 3187 via a 92-4 vote. Oval Office next

June 27, 2012
By Mark McCarty
The Senate passed the FDA user fee bill for fiscal years 2013-2017 by a majority of 92-4, sending the bill on to the White House where President Obama is expected to quickly apply his signature. The voting process did not come off without a hitch, however, as one member of the Senate put up a fight over the absence of provisions for track-and-trace of pharmaceuticals. Sen. Bernie Sanders (I-Vermont), a bitter critic of the pharmaceutical industry, provided one of only four nay votes, joined by Sen. Tom Coburn (R-Oklahoma), one of the authors of a late-stage track-and-trace amendment.
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Washington roundup: Durata failure due to external abrasion, but some not sold

June 26, 2012
By Mark McCarty

FDA advisory committee: Tissue sparing considerations drive 'aye' vote for MarginProbe

June 25, 2012
By Mark McCarty

The implications and future of TAVR

June 24, 2012
By Mark McCarty
The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching. One: Coverage does not equal adequate reimbursement David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals. Cohen said the Medicare...
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Washington roundup: FDA indicates problems with pivotal trial for MarginProbe

June 22, 2012
By Mark McCarty
View All Articles by Mark McCarty

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