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Limited Evidence for Phenylephrine Effectiveness: FDA

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FDA tells the Nonprescription Drugs Advisory Committee there is little evidence that OTC decongestants containing phenylephrine ac...

Citizen Group Wants Tobacco Bill Shelved

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A citizen advocacy group urges Congress not to burden FDA with tobacco regulatory authority.

Industry Urged to Support Doubling FDA Resources

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FDA Science Board members call on regulated industry to support a doubling in FDAs appropriated resources over the next five year...

Watson and Biovail Settle Generic Cardizem Case

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Watson Pharmaceuticals and Biovail Laboratories come to terms over an outstanding patent litigation involving a generic version of...

Activists Ask FDA to Reconsider Conflict Advice

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Five science and consumer activists groups ask FDA commissioner Andrew von Eschenbach to reconsider an advisory committee conflict...

FDA Fast Track on AVI BioPharma Therapy

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FDA grants fast track to AVI BioPharma for AVI-4658, an investigational therapy for treating Duchenne muscular dystrophy.

FDA Proposes Good Manufacturing Practice Revision

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FDA proposes several revisions to its GMP regulations to modernize requirements for drug and biologic manufacturers.

How Much Improvement Must Avastin Make?

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FDAs Oncology Drugs Advisory Committee is asked to consider what efficacy measure is appropriate for Genentechs Avastin to be appr...

High Court Hearing Device Preemption Case

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Medtronic tells the Supreme Court it should not be sued by someone using an FDA-approved medical device.

FDA Sends Info on CGMPs for Type A Medicated Articles to OMB

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Federal Register Notice: FDA submits a proposed collection of information on CGMP regulations for Type A medicated articles to the...