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FDAs Drug Safety Not Flawed But Can be Better: Industry

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Calling the U.S. drug safety system the gold standard and not seriously flawed, biotech and drug industry organizations neverthele...

Former HHS Leaders Head 2nd FDA Support Group

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A second coalition of patient, consumer, and industry groups announces its formation to build public support and funding for FDA.

Genentechs Avastin Gets Brain Leak Warning

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Genentech and FDA advise healthcare professionals and patients about a new warning added to Avastins (bevacizumab) labeling about ...

Using 'Terror' Money, FDA Lassos New Cow Culprits

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Consulting editor John Scharmann finds FDA using war on terror funds and some unusual regulatory inventiveness to place drug-resid...

Panel to Discuss Major Depressive Disorder PMA

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Federal Register Notice: FDAs Neurological Devices Panel will meet 10/31 to discuss a PMA intended to treat major depressive disor...

Oscients Factive is Approvable for 5-Day CAP

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FDA issues an approvable letter to Oscient Pharmaceuticals for its sNDA for a five-day treatment of community acquired pneumonia w...

Advisors Back Continued Trasylol Use

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FDAs Cardiovascular and Renal Drugs Advisory Committee votes to recommend continued use of Bayers Trasylol in CABG patients.

FDA Drug Safety Oversight Impaired, IoM Says

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An Institute of Medicine report assessing FDAs drug safety oversight finds it impaired because of poor organizational cultures, ch...

DeLauro Drafts Womens Health Bill

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Rep. Rosa DeLauro says she will introduce legislation to ensure that science is all that drives FDA decisions involving womens hea...

Risk Info Not In VoSpire Sample Letter

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DDMAC says a Dava Pharmaceuticals sample request letter for VoSpire ER omitted all risk information, making the drug appear safer ...