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Animal Drug Regs Implement Manufacturing Changes

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Federal Register Final rule: FDA amends its animal drug regulations to implement the manufacturing changes provisions for suppleme...

Celgene Challenges Barr ANDA for Thalidomide

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Celgene Corp. says it will file a patent infringement suit against Barr Pharmaceuticals over its ANDA for a generic copy of Thalom...

FDA OKs Blood Screening Test for Chagas Disease

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FDA approves Orthos Ortho T. cruzi ELISA Test System the first test used for screening blood donors to detect a blood-borne paras...

Committees Asked to Consider Ketek MedGuide

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FDA asks two advisory committees whether additional provider education and a MedGuide are the best ways to deal with adverse event...

FDA Wants More Info on Pozens Trexima

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Pozen officials say they will submit a revised response to FDAs approvable letter on Trexima by years end.

FDA to Review Sanctura XR NDA

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FDAs PDUFA target date for reviewing Indevus Pharmaceuticals NDA for Sanctura XR is 8/13/07.

New DoD Anthrax Suit Filed

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Service members and contractors file suit against the Defense Department and FDA over reinstatement of a mandatory anthrax vaccina...

Drug Safety Board Mulls Antibiotic Adverse Events

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CDERs Drug Safety Oversight Board reviews adverse events reported in patients separately taking fluoroquinolone antibiotics and dr...

Grassley Ramps Up Ketek Probe

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On the eve of an advisory committee review, outgoing Senate Finance Committee chairman Chuck Grassley sends FDA a 53-page complain...

FDA Sends Info on Labeling in e-Format to OMB

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Federal Register Notice: FDA sends a proposed collection of information on the requirements for submission of labeling for human p...