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Talecris Biotherapeutics to Begin Trial in Emphysema Patients

[ Price : $8.95]

Talecris Biotherapeutics plans a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of Prolastin-C ...

How to Speed Label Reviews, Even Those Affecting Pregnancy

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FDA officials provide tips on facilitating product label reviews, including preview of forthcoming changes to labeling requirement...

Watson Asks Bioequivalence Limits on Generic Androderm

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Watson asks FDA not to approve any ANDA for generic Androderm that doesnt include a study of time to reach maximum testosterone fo...

FDA Clears Disposable Insulin-delivery Device

[ Price : $8.95]

FDA clears a Valeritas 510(k) for the V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin.

McNeil Wants High Court Review of OTC Preemption Case

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McNeil asks the Supreme Court to decide whether federal law preempts state failure-to-warn suits for OTC drugs.

Feds Creating Drug Development Center

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NIH recommends creating a new federal center to partner with industry in drug development.

Special Protocol Assessment Reached for Prostate Cancer Vaccine

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FDA and Bavarian Nordic A/S reach agreement on a Special Protocol Assessment for a Phase 3 study involving the vaccine Prostvac, i...

Kos Paying $41 Million to Settle Charges

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Kos Pharmaceuticals agrees to pay $41 million to resolve whistleblower anti-kickback and false claims suits.

FDA Posts Safety Labeling Changes to 37 Products

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FDA approves safety labeling changes for 37 drugs, including anaphylactic reactions for 10 neuromuscular blockers.

FDA Funds IoM Review on Pediatric Studies

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FDA funds a new Institute of Medicine review on pediatric drug and biologic studies requested under the Best Pharmaceuticals for C...