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Pathways to Approval of Pediatric Cardiac Devices in the United States: Challenges and Solutions
Pediatrics, 07/10/09
Beekman RH et al. - This report authors review current US Food and Drug Administration regulatory processes, review some unique aspects of pediatric cardiology and cardiac surgery that pose challenges to these processes, and discuss possible alternate pathways to cardiac device evaluation and approval for children. Children deserve to benefit from new and refined cardiac devices and technology designed explicitly for their conditions.
Today in Cardiac/Hypertension...keeping you current
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Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09
Systematic Review: Comparative Effectiveness and Harms of Combination Therapy and Monotherapy for Dyslipidemia
Annals of Internal Medicine, 11/03/09
Choosing among renin-angiotensin system blockers for the management of hypertension: from pharmacology to clinical efficacy
Current Medical Research and Opinion, 11/20/09
Today in Drug Approvals...keeping you current
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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, 10/22/09
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, 09/10/09
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Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
Generic Anticonvulsant Use in Children: Do We Have Evidence to Recommend Brand Formulations?
Archives of Neurology, 11/23/09
FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Gen-Probe, 11/02/09
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