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FDA Searching for CDER Director

[ Price : $8.95]

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...

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 Henry Waxman asks FDA commissioner Andrew von Eschenbach not to proceed with a draft guidance allowing companies to distribut...

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...

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...

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...

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.