FDA Panel Backs Sapien Heart Valve
Posted on 20. Jul, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel has voted 9-0, with one abstention, to recommend approval for Edwards Lifesciences’ Sapien transcatheter heart valve — a novel device intended as an alternative for patients with severe aortic stenosis who are too frail for open-heart surgery.
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FDA Panel Narrowly Endorses Bone Graft Device
Posted on 12. May, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel narrowly recommended approval for an investigational bone graft device that uses a growth factor protein to regrow bones in the foot and ankle.
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Brain Tumor Blaster Endorsed by FDA Panel
Posted on 17. Mar, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel says the benefits of a novel device that blasts glioblastoma multiforme brain tumors with an electrical field outweigh any risks.
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FDA Panel: Keep ECT Devices as High Risk
Posted on 28. Jan, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency’s Neurological Devices Advisory Committee agreed.
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GI Panel Votes on Ulcers as Endpoints; GERD
Posted on 05. Nov, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — The FDA’s Gastrointestinal Drugs Advisory Committee took up two issues this week: whether ulcers can serve as an endpoint in trials testing drugs that prevent upper gastrointestinal toxicity and the role of proton pump inhibitors (PPIs) in treating infants with gastroesophageal reflux disease (GERD).
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FDA Panel Looks at Trials of Devices to Treat Depression
Posted on 08. Oct, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel met Friday to discuss how to analyze trials designed to test devices used to treat depression, but didn’t offer the FDA any clear-cut guidance.
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Keep Rosiglitazone on the Market, FDA Panel Says
Posted on 14. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — An advisory panel voted 20-12 to recommend that the FDA allow rosiglitazone (Avandia) to stay on the market, but most panelists want to see the controversial diabetes drug carry tougher warnings on its label.
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FDA Staffers Blast Rosiglitazone at Advisory Panel Meeting
Posted on 13. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — The two major FDA critics of rosiglitazone (Avandia) again denounced the diabetes drug during the first day of an advisory committee meeting that will end with a vote on whether the agency should pull it from the market.
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Panel Tells FDA to Keep Rotavirus Vaccines Available
Posted on 07. May, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — Members of an FDA advisory panel agreed that the two approved rotavirus vaccines — Merck’s RotaTeq and GlaxoSmithKline’s Rotarix — should continue to be used, despite known contamination with a pig virus.
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