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Science and Safety
PharmExec, 10/16/09

New leaders at the Food and Drug Administration are moving aggressively to address charges of incompetence and ineffectiveness that have roiled the agency in recent years. The Government Accountability Office (GAO) added FDA to its High–Risk list of government programs at the beginning of the year, largely due to inadequacies in drug oversight. GAO and other critics acknowledged perceived shortfalls in government funding as a prime factor, along with the rising complexity of medical technology and increased globalization of biomedical production.

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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/27/09

Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09

Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/09/09

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Today in Regulatory Issues...keeping you current

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Retigabine Regulatory Update
GlaxoSmithKline, 11/03/09

Review calls for EHR action in Saskatchewan
Canadian Healthcare Technology, 11/20/09

New Drug Application Filed for Eldecalcitol, An Active Vitamin D3 Derivative
Chugai Pharmaceutical Co., 11/04/09

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