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ZymoGenetics Wants King Thrombin-JMI BLA Revoked

[ Price : $8.95]

ZymoGenetics says that FDA should revoke King Pharmaceuticals BLA for Thrombin-JMI because its risks outweigh its benefits.

Sandoz Wants Paragraph 4 Certifications in Actos ANDAs

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Sandoz asks FDA to require Teva and Alpharma to submit Paragraph 4 certifications as part of their ANDAs for generic Actos.

Where is the Real Meaning in Transparency?

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Consulting editor John Scharmann reviews various misadventures in governmental transparency and concludes that until both the exec...

Bad Readings in Philips Avalon Fetal Monitors

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FDA says there have been complaints of inaccurate readings with four specific Philips Avalon fetal monitors.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ANIP Acquisition Co., Biomed Devices, Cambrex Profarmaco Milano, Cooley Dickinso...

Pure Red Cell Aplasia Associated with Myfortic

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Novartis revises Myfortics labeling to warn of a potential for patients developing pure red cell aplasia with its use.

Companies, FDA Agree on Advisor Review of Acurox

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FDA says an advisory committee will be asked to review the abuse potential of Acura and Kings oxycodone/niacin drug Acurox.

No Danger in the Lead in Lipstick: FDA

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FDA swiftly rebuts criticism that it hid for two years the danger of lead in lipstick, revising its Web site saying there is no da...

FDA Asks Court to Close Care-Tech

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FDA seeks a permanent injunction to close Care-Tech Laboratories St. Louis OTC drug manufacturing facility for repeated and contin...

FDA Says Cervarix Appears Safe and Effective

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FDA asks the Vaccines and Related Biological Products Advisory Committee to assess safety and efficacy of GlaxoSmithKlines Cervari...