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FDA Wins in Court Over Compounded Makena Enforcement Discretion

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A Washington, DC federal judge dismisses a KV Pharmaceuticals lawsuit against FDA that sought to reverse a recent agency notice ex...

FDA Warns Concussion Supplement Marketers

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FDA sends Warning Letters to PruTect Rx (Highlands Ranch, CO) and Trinity Sports Group (Plano, TX) for promoting dietary supplemen...

Industry Praises Guidance on Transferring Clinical Oversight

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Five drug companies express general support for an FDA draft guidance on transferring clinical oversight responsibility from one I...

Alimta Study Fails to Meet Primary Endpoint

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Lilly says a Phase 3 trial of its cancer drug Alimta failed to meet its primary endpoint of improved overall survival.

FDA Defends Expedited Reviews After Critical Journal Article

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FDA defends its expedited review programs in the wake of a Journal of the American Medical Association article criticized the agen...

Priority Review for Janssens Bedaquiline

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FDA gives priority review to Janssens bedaquiline for treating some adults with tuberculosis.

New Arthritis Biologics Don't Increase Cancer Risks: Researchers

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University of Texas MD Anderson Cancer Center researchers say that biologic therapies approved in the last decade for rheumatoid a...

Genomic Information Can Help Target Drug Development

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An Institute of Medicine workshop summary examines how genomic information can be used to improve the drug discovery and developme...

Sun Recalls One Lot of Nimodipine

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Sun recalls one lot of nimodipine capsules marketed by Caraco due to crystallization of fill material.

Sunovion Wants Generic Lunesta Requirements

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Sunovion petitions FDA to place conditions on possible approval of a Dr. Reddys ANDA for generic Lunesta.