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FDA Seeks New Trial for Vion Drug

[ Price : $8.95]

FDA issues Vion Pharmaceuticals a complete response letter for its NDA for Onrigin (laromustine) injection, finding the submission...

Panel to Consider Best Use of Tarceva

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FDA asks its Oncologic Drugs Advisory Committee to consider whether Roche/OSIs Tarceva should be approved as a first-line maintena...

FDA Wins Flavored Rolling Papers Suit

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Attorney Arnold Friede says that an Arizona federal court decision dismissing a suit challenging an FDA guidance on products cover...

FDA Cuts Azilect Restrictions

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FDA approves reduced medication and food restrictions for patients taking Tevas Azilect.

FDA Updates 2 Drug Shortages, 1 Deletion

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FDA updates drug shortage and discontinuation information for methotrexate injection, mitomycin for injection and Vesanoid respect...

Advisors Asked About Crestor Safety Concerns

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FDA asks the Endocrinologic & Metabolic Drugs Advisory Committee to comment on safety concerns from a trial of AstaZenecas Crestor...

Rx Drug Import Amendment Stalls Senate Reform Bill

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Senators stake out opposing positions on drug importation and threaten to block consideration of overall healthcare reform legisla...

Change of Animal Drug Sponsor to Janssen

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Federal Register Final rule: FDA amends its animal drug regulations to reflect a NADA sponsor change to Janssen Pharmaceutica.

Comments Extended on Combo Product Safety Reporting

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Federal Register Proposed rule: FDA extends the comment period for a proposed rule requesting comments on postmarketing safety rep...

FDA Fast Track for Breast Cancer Therapy

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FDA grants BiPar Sciences fast track status for BSI-201 for treating metastatic triple-negative breast cancer.