The US Food and Drug Administration remains concerned about drospirenone-containing oral contraceptives and increased risk for venous thromboembolism. Medscape Medical News
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WASHINGTON (MedPage Today) — The healthcare reform law is more likely than ever to end up in the Supreme Court — and fairly soon — because the Obama administration deliberately missed an important deadline on Monday for a lower court to rehear a case against the law.
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(MedPage Today) — Primary care physicians in the U.S. believe they are being forced to provide excessive care to their patients, particularly in terms of testing and referrals, a national survey found.
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WHITE OAK, Md. (MedPage Today) — The increasing number of drug shortages has a variety of causes and will require corrective action on a number of fronts, according to an FDA panel.
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WASHINGTON (MedPage Today) — The chairman of the board for the medical device industry’s biggest trade group said he does not believe that increasing user fees on device companies would lead to better-trained FDA reviewers.
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(MedPage Today) — Four months after announcing that it was reviewing the safety of certain drospirenone-containing oral contraceptives, the FDA said Monday that it still had not reached a conclusion.
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22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.
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The Nation examines how a surge in the outsourcing of clinical trials to contract research organizations (CROs) and a resulting increase in the number of trials being conducted in the developing world, where “regulations aren’t as onerous, patient recruitment is easier and informed consent is less clearly defined,” has led to a rise in unregulated [...]
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The Harvard Clinical Research Institute (HCRI) announced today that the enrollment phase of the DAPT Study has been successfully completed. The DAPT Study is a four-year clinical trial investigating the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.
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Afraxis, a San Diego-based biotechnology company developing drugs to treat rare genetic diseases through the modulation of p21-activated kinase (PAK), announced today that it has been selected to participate in the National Institutes of Health’s (NIH) Therapeutics for Rare and Neglected Disease (TRND) Program.
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