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FDA Lifts Clinical Hold on Alzheimers Drug

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FDA lifts a six-month clinical hold on Cortex Pharmaceuticals investigational drug Ampakine CX717 for treating Alzheimers disease....

Committee Members Want Major FDA Safety Changes

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Current and former members of FDAs drug safety advisory committee say there are major problems with the agencys approach to drug s...

New ADHD Drug Approvable

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FDA says New River Pharmaceuticals NRP104 candidate for once-daily treatment of ADHD in children six to 12 is approvable.

FDA OKs Merial Equine Ulcer Treatment

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Federal Register Final rule: FDA approves a Merial Ltd. supplemental NADA for administering omeprazole to horses for preventing ga...

FDA Modifies iPLEDGE Risk Program

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FDA approves a change to Roches Accutane and generic isotretinoin makers iPLEDGE risk management program to remove a prescribing r...

Wyeth Renal Cell Carcinoma NDA Submitted

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Wyeth Pharmaceuticals submits an NDA for Torisel, indicated for treating patients with advanced renal cell carcinoma.

New MedGuide on 'Bleeding' Approved for Coumadin

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FDA approves a revised medication guide to warn about major bleeding for patients taking Bristol-Myers Squibbs blood thinner Couma...

OGD Adopts New Drug e-Document System

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CDERs Office of Generic Drugs adopts an Office of New Drugs electronic file system for more efficient reviews and archiving.

OIG/DOJ Crawford Probe Alive and Kicking

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HHS inspector general Daniel Levinson tells lawmakers that his probe into the abrupt resignation of former commissioner Lester Cra...

FDA Seeks Injunction Against Device Maker

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FDA announces another court action against a medical product maker this time its a request for a permanent injunction against End...