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BioMerieux received a warning for its handling of complaints and nonconformances, including using roughly 546 complaint description codes that are not defined in company documents. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
Medtronic officials said Tuesday that a large donation to the Medtronic Foundation plus the ongoing acquisition of Covidien led to an 8 percent decline in earnings in the second-quarter of fiscal 2015 compared with the previous year. Read More
Cataract patients who also have astigmatism may soon have a new option for restoring vision, if the FDA heeds a recent advisory panel recommendation. Read More
Minneapolis, Minn.-based Vascular Solutions will not get a state subsidy for job creation in the wake of a federal fraud indictment issued against the company and its CEO. Read More
HHS officials highlighted progress in developing new Ebola diagnostics during a Wednesday House hearing, but acknowledged that more companies are looking for government support to move their products quickly to market. Read More
A study on the optimal length of dual antiplatelet therapy following implantation of a drug-eluting stent shows that 30 months is better than one year in preventing certain adverse outcomes. Read More
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
The American Clinical Laboratory Association and American Medical Association are promising an all-out fight to stop the FDA from requiring premarket applications for high-risk laboratory-developed tests. Read More