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FDA OKs Diovan for Pediatric Hypertension

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FDA approves a Novartis supplemental NDA for Diovan for use in treating high blood pressure in children and adolescents ages six t...

Waxman Wants Off-Label Promotion Draft Pulled

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Rep. Henry Waxman asks FDA commissioner Andrew von Eschenbach not to proceed with a draft guidance allowing companies to distribut...

FDA Searching for CDER Director

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After waiting 10 weeks, FDA opens a search for a new CDER director able to help define drug regulatory policy for the next generat...

FDA in Crisis: Science Board Unanimous on Recommendations

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Against a rising sense of crisis in FDAs ability to continue its mission, the agencys Science Board Advisory Committee unanimously...

Magics Wife Participating in AIDS Program

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Magic Johnsons wife Cookie joins his HIV campaign supported by Abbott to educate minority women about the disease.

FDAer Wants Diabetes Trial Changes

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CDER medical officer Robert Misbin urges changes to clinical testing of new diabetes drugs.

Doc Says DTC Genetics Tests Poorly Regulated

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Physician Erin Tracy says DTC ads for unregulated DNA tests can cause excessive alarm or false reassurance in consumers.

Info on Drug Producer Registration Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a comment request for registration of producers of dr...

Blood Cell Separator Reclassified

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Federal Register Final rule: FDA reclassifies to Class 2 the automated blood cell separator device operating by centrifugal separa...

Our Lives at Risk: Science at FDA Precarious

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An FDA Science Board subcommittee says FDA lacks the resources and capability needed to be an effective science-driven agency able...