Extended-Release Opioid Gets FDA OK
Posted on 26. Aug, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA has approved tapentadol (Nucynta), an extended-release oral opioid, to treat severe chronic pain.
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Washington Week: Generic Drug Makers to Pay User Fees
Posted on 20. Aug, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Despite the late summer doldrums, the FDA has been busy, announcing an important user-fee deal with generic drugmakers and releasing new guidance on its medical device approval process.
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Generic Makers to Pay Fees Like Big Pharma Does
Posted on 17. Aug, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — A new FDA user-fee program will require generic drugmakers to pay annual fees to speed up drug approvals and to increase inspections of foreign manufacturing plants.
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One More Plea for Avastin in Breast Cancer
Posted on 08. Aug, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — As Genentech awaits word from the FDA on whether bevacizumab (Avastin) will lose its breast cancer indication, the company is urging the agency to consider a “middle ground” approach that would continue the drug’s approval in metastatic disease.
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One More Plea for Avastin in Breast Cancer
Posted on 08. Aug, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — As Genentech awaits word from the FDA on whether bevacizumab (Avastin) will lose its breast cancer indication, the company is urging the agency to consider a “middle ground” approach that would continue the drug’s approval in metastatic disease.
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IOM Slams FDA Device Fast Track
Posted on 29. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA’s 510(k) fast-track approval process for medical devices does not ensure safety or effectiveness and needs to be replaced, the Institute of Medicine said in a report released Friday.
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FDA Considering Tighter Standards for Bioequivalency
Posted on 26. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory committee met Tuesday to discuss the agency’s proposed standards for determining when generic drugs can be considered bioequivalent to the brand-name version of the medication.
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Hamburg Answers Critics of FDA Approval Process
Posted on 25. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — FDA Commissioner Margaret Hamburg, MD, addressed on Monday the “increasing drumbeat” of criticism suggesting that the agency is slowing innovation by requiring drug and device companies to wait excessively long periods for approval.
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FDA Panel Backs Remicade for Kids With Ulcerative Colitis
Posted on 21. Jul, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory panel has recommended expanding the indication for infliximab (Remicade) to include treatment of ulcerative colitis in children.
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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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