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The Nuclear Regulatory Commission (NRC) has proposed a $44,400 fine against Baxter Healthcare for three violations stemming from an event earlier this year in which two workers failed to follow safety procedures when repairing a commercial irradiator at the company's Aibonito, Puerto Rico, facility.
Responding to a patent challenge from generic firm Eon Labs, drugmaker Dey has filed an amendment to an earlier citizen petition which entitles Dey—not Ivax, as originally identified—to a 30-month stay on its inhalation lung disease treatment, DuoNeb.
NIH has rejected a petition by an advocacy group seeking to break patents on Pfizer’s glaucoma drug Xalatan so that licenses could be issued for generic competition.
R&D spending by the pharmaceutical and biotechnology industries could be drastically reduced if prescription drug importation is permitted, according to a new report prepared by a conservative think tank.
Brand pharmaceutical companies are over-profiting from the difference in how the FDA and the Centers for Medicare & Medi-
caid Services (CMS) view authorized generics, according to the Generic Pharmaceutical Association (GPhA).
The Generic Pharmaceutical Association (GPhA) is asserting brand drugmakers reap huge financial windfalls as the result of competing best-price reporting requirements used by the FDA and the Centers for Medicare & Medicaid Services.
In a sudden policy shift, NIH has implemented a one-year moratorium on all staff consulting with pharmaceutical and biotechnology companies — a move that accelerates NIH’s earlier proposal to reduce employee conflicts of interest.