FDA Petitioned to Pull Novo Diabetes Drug
Source In a petition filed with the FDA, Public Citizen is asking the agency to withdraw the Victoza diabetes treatment sold by Novo Nordisk due to increased risks that patients may developed pancreatitis, serious allergic reactions and kidney failure. And citing internal agency documents, the consumer watchdog notes that Victoza was approved in early 2010 […]
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FDA: U.S. Marshals seize contaminated ultrasound gel from N.J. plant
U.S. Marshals have raided a New Jersey plant that produces ultrasound transmission gel at the request of the the U.S. Food and Drug Administration after the agency found product samples contained dangerous bacteria. Product lots of Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. in Newark, N.J, were seized by marshals because they […]
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FDA Warning: Infection Risks From Contaminated Ultrasound Gel
FDA is warning doctors, hospitals and clinics that contaminated ultrasound gel produced by a New Jersey company infected 16 cardiac patients and could pose serious risks to pregnant women and others who undergo ultrasound imaging and treatment. The gel is used by radiologists, urologists, gastroenterologists, OB-GYNs, internists, nurses and ultrasound technicians for diagnostic ultrasound testing. […]
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Parents Say Bad Tylenol Killed Baby
Parents say in court that contaminated Tylenol drops killed their infant son just 13 days before Johnson & Johnson recalled more than 136 million bottles of children’s Tylenol – the largest recall of children’s medicine in history. Malgorzata and Michael Cherry sued McNeil-PPC and Johnson & Johnson in Cook County Court. McNeil-PPC is a division […]
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Parents Say Bad Tylenol Killed Their Baby
Parents say in court that contaminated Tylenol drops killed their infant son just 13 days before Johnson & Johnson recalled more than 136 million bottles of children’s Tylenol – the largest recall of children’s medicine in history. Malgorzata and Michael Cherry sued McNeil-PPC and Johnson & Johnson in Cook County Court. McNeil-PPC is a division […]
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500 new jobs announced for Dublin and Galway
A PHARMACEUTICAL COMPANY has announced it is to create more than 500 new jobs in Dublin and Galway over the next four years. Mylan, one of the largest pharmaceutical companies in the world, said it plans to create 220 jobs in Galway and 280 in Dublin by 2016. The company is to invest up to […]
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J&J Ft. Washington Plant Won’t Reopen Until 2014
Source If you were wondering why the befuddled Johnson & Johnson executive team had to postpone the rebirth of its troubled Fort Washington, Pennsylvania, facility, consider this simple analogy. Imagine an old kitchen that was used to make great food, but once-exquisite meals gradually became horrible – tasty dishes began smelling funny and looking bad […]
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FDA Warns of Propecia and Proscar Sexual Side Effects
Last week the U.S. Food and Drug Administration (FDA) followed up a new blood clot warning for some birth control medications with an announcement that the labels for Propecia and Proscar would be updated as well. These medications, which contain finasteride, have been linked to several sexual side effects in the men who take them. […]
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States Go After High-Prescribing Doctors
Source If this sounds familiar, it is because we are keeping tabs on the steps that states are taking to monitor doctors who write large numbers of prescriptions for particular drugs that are paid for by Medicaid programs. Why? For the past two years, US Senator Chuck Grassley has pressed all 50 states to provide […]
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FDA IT Systems Stink
source We all know that information technology can be a complex and sometimes confusing universe. But without IT, much could not get done. Take the FDA. The agency relies on IT to review products, collate adverse events reports and maintain compliance, among many other things. So having an up-to-date system is important. Unfortunately, the agency […]
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