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FDLI to Honor Beardsley, Landa, Silverglade and Taylor

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Well known food and drug lawyers Kate Beardsley, Michael Landa, Bruce Silverglade and Michael Taylor are honored by the Food and D...

FDA Taking First Amendment Challenges Seriously: Samp

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Washington Legal Foundation chief counsel Richard Samp says the federal governments decision to seek permission for one of its vet...

IND Approved for Inhaled Nitric Oxide in Pulmonary Hypertension

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FDA approves a GeNO IND for a clinical trial with the GeNO Nitrosyl (inhaled nitric oxide) System for treating certain pulmonary h...

Advisors Back Restricted Vandetanib Use

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Members of FDAs Oncologic Drugs Advisory Committee signal support for AstraZenecas vandetanib in some thyroid cancer patients.

Comments Sought on Animal Drug User Fee Info

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Federal Register Notice; FDA seeks comments on reporting requirements for animal drug user fees.

Panel to Discuss NDA for Exocrine Pancreatic Insufficiency

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory will meet 1/12 to discuss an Alnara Pharmaceuticals NDA to treat exo...

Is FDA Planning Court Action Against McNeil?

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Increased FDA pressure directed at Johnson & Johnson's McNeil drug unit could spell out a pending federal court action taking shap...

Synthes and Norian Plead Guilty to Unauthorized Device Tests

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Synthes and Norian formally enter guilty pleas to charges involving unauthorized clinical tests of two bone cement products.

Reviewers Have Questions on Expanded Lap-Band Indication

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FDA reviewers ask the Gastroenterology and Urology Devices Advisory Panel to comment on whether Allergan has demonstrated the prac...

Shire Plans NDA Resubmission for Firazyr

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Shire says it plans to resubmit early next year an NDA that was rejected by the agency in 2008 for Firazyr (icatibant), indicated ...