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FDA Alliance Hires Patton Boggs as Lobbyist

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The FDA Alliance hire Washington attorneys Stuart Pape and Ed Newberry (Patton Boggs) as its lobbyists to pursue high congressiona...

Guidance Out on Bio Product Deviation Reporting

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CBER finalizes a guidance with its thinking on reporting biological product deviations.

Drug Distributor Guilty Plea in Counterfeit Case

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Albers Medical Distributors owner Douglas Albers enters a guilty plea for his role in selling counterfeit and misbranded Neupogen ...

New Indication for Taxotere

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FDA approves using Taxotere with cisplatin and fluorouracil for treating head and neck squamous cell carcinoma.

Dispute Resolution Panel to Hear Acorn Appeal

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CDRHs Medical Device Dispute Resolution Panel will consider whether an additional clinical trial is needed for Acorn Cardiovascula...

Risk Fears Led to Natrecor De-adoption

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Research shows many physicians stopped prescribing Natrecor after publication of articles questioning its safety.

Needless Fear Makes Drug Firms Shun Dispute Resolution: Jenkins

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CDER Office of New Drugs director John Jenkins tells RAPS that drug sponsors still dont use the dispute resolution process as much...

Drug Safety Alerts the Norm Despite Labeling Talks: Seligman

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CDER safety policy and communication associate director Paul Seligman says the Center will continue releasing emerging drug safety...

Faster FDA Reviews for Priority Generics

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CDER director Steven Galson announces a new policy for expediting reviews of generic products that meet certain priority criteria....

18 Drug Companies in Top 200 Brands

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Ad Age says 18 drug companies placed in the Top 200 advertisers for the first half of 2006 based on their ad spending.