Washington Week: Finally, A Longer-Term SGR Fix
Posted on 11. Dec, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Congress passed a year-long doctor payment fix this week, and an FDA advisory panel endorsed what could become the first new pharmaceutical option in weight loss in a decade.
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US Lags Behind in Health IT
Posted on 30. Oct, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Countries such as Sweden, the Netherlands, New Zealand, the United Kingdom and Norway have nearly universal adoption of health information technology (HIT) while the United States lags painfully behind.
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TCT: Both Sides Vent During FDA Town Hall
Posted on 25. Sep, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — During a day long “FDA town hall” here makers of medical devices for the heart like drug-eluting stents, prosthetic valves, and pacemakers vented their frustration over process, while the FDA countered with laments about the quality of evidence submitted to support approvals — and no one walked away satisfied.
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Improve Fast-Track Approval Process for Some Medical Devices: FDA Staff
Posted on 03. Aug, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA has issued two reports aimed at improving the controversial fast-track approval process used by the agency’s Center for Devices and Radiological Health (CDRH) for low- to mid-risk medical devices.
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Washington Week: Nonstop Action As FDA Closes Out July
Posted on 31. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — It’s been an unusually hectic July for the FDA, and this past week was no exception. The agency approved a polypill to treat hypertension, and separate FDA advisory committees endorsed an investigational antiplatelet, grappled with safety issues involving a new spine device, and debated when it’s okay to change endpoints in clinical trials.
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Federal Panel Endorses Ticagrelor for ACS
Posted on 28. Jul, 2010 by Dr. Ellis in News and Updates
ADELPHI, Md. (MedPage Today) — An FDA advisory panel has voted overwhelmingly to recommend approval of AstraZeneca’s investigational antiplatelet drug ticagrelor (Brilinta), saying it appears more effective than clopidogrel (Plavix) for patients with acute coronary syndrome who will be treated either medically or with PCI.
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FDA Panel to Vote on Blood Thinner Ticagrelor
Posted on 27. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — FDA reviewers said AstraZeneca’s investigational antiplatelet ticagrelor (Brilinta) appears more effective than clopidogrel (Plavix) for patients with acute coronary syndrome, but expressed concern that the findings didn’t hold up in a U.S. population.
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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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Advisory Panel Faces Tough Call on Rosiglitazone, Experts Say
Posted on 12. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Despite hints that the FDA may be leaning toward pulling rosiglitazone (Avandia) from the market, it’s going to be a tough decision for the advisory committee slated to begin meeting on Tuesday, and things could still go either way, leading endocrinologists predict.
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FDA Okays Generic Venlafaxine
Posted on 30. Jun, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA has approved the first generic version of the antidepressant venlafaxine (Effexor XR).
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