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Comments Sought on Corrections & Removals

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Federal Register Notice: FDA seeks comments on Reports of Corrections and Removals 21 CFR Part 806.

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.

Gilead and Truvada Submit NDA for HIV Combo Pill

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Gilead Sciences files an NDA for a combination pill containing Truvada and Tibotec Pharmaceuticals investigational non-nucleoside ...

Vertex Completes Telaprevir NDA Submission

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Vertex says its telaprevir NDA submission is complete with results from three Phase 3 studies.