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FDA Panel
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Swedish Match's Proposal Has Not Been Accepted by a Panel of US FDA Advisors
Apr 16, 2015Swedish Match’s proposal to ease warning labels related to snus tobacco packaging has not been accepted by a panel of US FDA advisors. Snus is a moist tobacco powder put under the upper lip. Swedish Match wants the FDA to allow it ...
Tags: Snus Packs, FDA Panel, moist tobacco powder
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FDA Disagrees with Swedish Match's Proposal
Apr 14, 2015Swedish Match’s proposal to ease warning labels related to snus tobacco packaging has not been given a clearance by US FDA. Snus is a cloth baggie with moist tobacco powder and has to be put under the upper lip by consumers to ...
Tags: Snus Packaging, Swedish Match, Packaging
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FDA Panel Recommends Approval for Bard's Drug-Coated Balloon
Jun 16, 2014FDA's Circulatory System Devices Advisory Panel has submitted a unanimous approval recommendation for C.R. Bard's Lutonix Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) catheter. If FDA follows the recommendations ...
Tags: Health, Medicine, FDA, Certification
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Naproxen Is Safer for The Heart Than Other Popular Anti-inflammatory Drugs
Feb 25, 2014TUESDAY Feb. 10, 2014, 2014 -- The science isn't convincing enough to say that naproxen -- the key pain reliever in Aleve -- is safer for the heart than other popular anti-inflammatory drugs such as ibuprofen (Advil and Motrin), U.S. health ...
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Bayer HealthCare Has Failed to Win The Backing of The US FDA's Cardiovascular
Jan 20, 2014Bayer HealthCare has failed to win the backing of the US FDA's Cardiovascular and Renal Drugs Advisory Committee to expand the use of its oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard ...
Tags: FDA Panel, ACS Patients
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A Implant Offers People Suffering From Sleep Apnea an Alternative to Wearing an Air Mask
Jan 10, 2014A new kind of implant may offer people suffering from sleep apnea an alternative to wearing an air mask while they snooze, researchers report. With the implant, a pacemaker delivers electrical impulses to a nerve that controls the tongue ...
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Boston Scientific's Watchman Left Atrial Appendage Closure Device Is Voted by FDA Panel
Dec 13, 2013The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority that the benefits of the Boston Scientific's WATCHMAN left atrial appendage closure device ...
Tags: FDA, Boston Scientific, WATCHMAN, left atrial appendage closure device
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FDA Has Recommended The Expanded Indication of Medtronic's CRT-P and CRT-D
Oct 10, 2013The US Food and Drug Administration (FDA) advisory panel has recommended the expanded indication of Medtronic’s cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D) for the treatment of patients who ...
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FDA Has Recommended The Approval of Investigational Copd Drug in US
Sep 13, 2013The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol as a treatment for chronic obstructive ...
Tags: Health, Medicine, Investigational Copd Drug
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US FDA Panel Decide on Ocular Premarket Approval Application for The Resure Sealant
Aug 12, 2013The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health
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NDAC Has Recommended Approval of Sanofi's Nasacort AQ Nasal Spray
Aug 2, 2013The US FDA Nonprescription Drugs Advisory Committee (NDAC) has recommended approval of Sanofi's Nasacort AQ nasal spray (triamcinolone acetonide) for over-the-counter use in the country. Nasacort AQ Nasal Spray is indicated to treat the ...
Tags: Nasacort AQ Nasal Spray, Medicine
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The Argus II System Is Used in Patients with Severe to Profound Retinitis Pigmentosa
Dec 18, 2012The Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has scheduled to review the data presented in the Second Sight Medical Products' humanitarian device exemption (HDE) market approval application, for its Argus II ...
Tags: FDA, Argus II System, medical technology
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