FDA Staff Sees Only Minor Issues for Telaprevir
Posted on 26. Apr, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — An FDA staff assessment gave high marks to the investigational hepatitis C drug telaprevir, suggesting that the agent will sail easily through an advisory committee review on Thursday.
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FDA Panel to Vote on Two Drugs for Pancreatic Cancer
Posted on 11. Apr, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA’s Oncology Drugs Advisory Committee will meet Tuesday to vote on whether approval should be granted for two new drugs to treat advanced pancreatic neuroendocrine tumors (pNET).
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Washington Watch: FDA Active, ACA Ruling Appealed
Posted on 12. Mar, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The Obama administration finally filed its appeal against the ruling by the Florida judge who declared the healthcare reform law void; a Medicare official projects a steep pay cut for doctors in 2012; and the FDA had a busy week of advisory committee hearings.
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Washington Week: ACA Debated, Imaging Device Okayed
Posted on 12. Feb, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Congressional panels continued to hold hearings on the healthcare reform law, while the FDA this week approved a new 3-D breast imaging device and heard from an advisory committee that called for stricter standards for cancer drug trials.
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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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Stent Works Well in Lower-Risk Cases, FDA Staff Says
Posted on 24. Jan, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Abbott Laboratories’ RX Acculink Carotid Stent System appears safe and effective in carotid endarterectomy patients who are lower-risk than those who currently receive the stent, FDA reviewers said in advance of an advisory committee hearing.
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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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Washington Week: Stem Cells and Diet Pills
Posted on 18. Sep, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Congress is back from summer recess, and, as promised, a Senate panel made a hearing of embryonic stem cell research its first order of business. Meanwhile, the FDA held three advisory committee hearings this week, handing down recommendations on cough syrup and diet drugs.
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CMS to Consider Evidence on Bone Growth Agent
Posted on 30. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) will meet in September to consider available evidence for using bone morphogenetic protein (BMP) for a number of on-label and off-label uses.
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Endocrinologist Reflects on Rosiglitazone
Posted on 22. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — As the FDA processes the vote and discussion from last week’s advisory committee meeting on rosiglitazone (Avandia), an endocrinologist who has twice voted to keep the diabetes drug on the market dissected what the recent vote means in a perspective published in the New England Journal of Medicine.
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