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BioWorld - Tuesday, January 27, 2026
Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Washington roundup: Sientra's breast implant PMA approved in glare of PIP flap

March 13, 2012
By Mark McCarty

Washington roundup: FDA eyes clinical trials but says little of OUS trial data

March 12, 2012
By Mark McCarty

FDA user fees: A necessary evil?

March 9, 2012
By Mark McCarty
The FDA medical device review mechanism has come under fire from many quarters for some time now, but one of the criticisms of the 510(k) and PMA programs is that the reviews are funded by user fees, a claim that can be made of pharmaceuticals, biotech and now even FDA’s overview of food production. Opponents can complain all they want about user fees, but what can they do about them? As has been widely reported, the Obama administration has proposed that FDA’s total budget for FY 2013 would rise by double-digit percentages, but 98% of that increase comes from...
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Washington roundup: Norovirus reagent guidance for pandemic gastroenteritis

March 9, 2012
By Mark McCarty

Washington roundup: IRB guidance hints at more workload for sponsors, sites

March 8, 2012
By Mark McCarty

Washington roundup: FDA wants routine audits of Synthes USA after inspection

March 7, 2012
By Mark McCarty

Washington roundup: Edwards expresses dismay with CMS's superiority trial mandate

March 6, 2012
By Mark McCarty

Washington roundup: Registration fee exemptions to disappear in MDUFA III

March 5, 2012
By Mark McCarty

Washington roundup: FDA eyes doc label rule for devices; may expand liability

March 2, 2012
By Mark McCarty

Washington roundup: Rogers: House may not match White House on FDA approps

March 1, 2012
By Mark McCarty
View All Articles by Mark McCarty

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