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House Lawmakers Seek Hearing on Provenge

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Several congressmen ask House Energy and Commerce leaders to hold a hearing to examine alleged conflicts of interest involving FDA...

Consumers Prefer OTC Statins: Merck-funded Study

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A Merck-funded National Consumers League survey finds people want an OTC statin.

For 3rd Time, Advisors Nix OTC Mevacor

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For the third time in 7 years, an FDA advisory panel knocks back a Merck bid to switch the statin Mevacor to over-the-counter stat...

Health and Diet Info Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a health and diet survey to the Office of Management an...

Parents Dont Trust FDA for Info on OTC Drugs

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Parents of young children dont think FDA is trustworthy as an information source on OTC childrens drugs.

FDA Fast Track for Parkinsons Gene Therapy

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FDA grants Neurologix, Inc. fast track for its experimental gene transfer procedure indicated for treating advanced Parkinson's di...

FDA 2nd Approvable Letter on Insomnia Drug

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FDA issues a second approvable letter to Neurocrine Biosciences for its insomnia drug indiplon 5 mg and 10 mg capsules.

Electric Handpieces Causing Burns

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CDRH says patients can suffer significant burns from poorly maintained electric dental handpieces.

UCB Submits Neupro sNDA

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FDA accepts a UCB supplemental NDA for a new indication for Neupro to treat moderate to severe restless leg syndome.

Solvay to Answer Advisors Questions

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Solvay Pharmaceuticals says it will respond to questions raised by FDA advisors who recommended against approving the companys ted...