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Agenda Changed for Oncologic Drugs Panel Meeting

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Federal Register Notice: FDA amends the notice of a 12/2 meeting of the Oncologic Drugs Advisory Committee to postpone a discussio...

Appeals Court Rejects Vermont Doctor Information Law

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A federal appeals court rejects a Vermont law that tried to restrict health information company access to prescribing information.

FDA Says Hologic Selenia System Approvable

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FDA issues an approvable letter for Hologics Selenia Dimensions 3-D digital mammography system.

Heart Failure Test Cleared by FDA

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FDA clears a BG Medicine 510(k) for the Galectin-3 test for use in conjunction with clinical evaluation to help assess the prognos...

More Recalls at McNeil Consumer Health Unit

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Johnson & Johnson's McNeil Consumer Health notifies FDA that it is recalling about 4 million packages of Children's Benadryl Fastm...

FDA Denies Propofol Petition

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FDA denies a citizen petition seeking enforcement action against Bedford Laboratories generic Diprivan for lack of conformity to c...

FDA Top Criminal Investigator to Retire

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FDA Office of Criminal Investigations director Terry Vermillion announces his retirement effective next month.

Impax Sued Over ANDA for Generic Welchol Suspension

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Daiichi Sankyo and Genzyme file a patent infringement suit against Impax Laboratories over a recently submittied ANDA for a generi...

Omthera Pharma Gains Protocol Agreement for Epanova Trial

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Omthera Pharmaceuticals and FDA reach agreement on a special protocol assessment on a planned Phase 3 trial involving Epanova for ...

FDA Allows Stem Cell Trial for Macular Degeneration

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FDA approves an Advanced Cell Technology IND to begin a Phase 1-2 multicenter clinical trial using retinal cells derived from huma...