The Health Policy Exchange
MAY 20, 2013
Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. Approval from the U.S. The size of average doses would more than triple.
FDA Law Blog
AUGUST 21, 2023
After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v.
FDA Law Blog
MAY 19, 2022
By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C. See 42 C.F.R. §§ 447.505(c)(8)-(12).
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