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FTCer Wants Follow-on Legislation to Protect Consumers

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FTC commissioner Pamela Harbour says Congress must take steps to preserve competition in any pathway for approval of generic biolo...

Drug Company Doc Payments Higher Than Thought

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Public Citizen says drug company payments to Vermont healthcare providers were much higher than originally thought and that many o...

Panel to Discuss Solvay NDA for Pancreatic Insufficiency

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Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 12/2 to discuss safety and efficacy of a Solvay Pharmac...

Panel to Discuss ReGen PMA for Meniscus Repair

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 11/14 to discuss ReGen Biologics PMA for the R...

Panel to Discuss Fujirebio Ovarian Cancer Test

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Federal Register Notice: FDAs Immunology Devices Panel will meet 12/3 to discuss a Fujirebio PMA for an assay kit and Risk of Mali...

FDA Drug Approvals on Track to Surpass 2007 Dismal Results

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Just-released new drug approval reports show that FDA is on track to barely surpass last years approvals.

Medication Error Warning Added to Heparin Labels

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Heparin warnings for children lead labeling changes issued by for 36 drugs in September.

Drug Preemption Oral Argument Transcript Available

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The U.S. Supreme Court posts a transcript of the 11/3 oral argument in Wyeth v Levine federal preemption case.

FDA Rejects Comparability Data on Long-acting Byetta

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FDA tells Amylin Pharmaceuticals that recently submitted comparability data are inadequate to support a long-acting formulation of...

FDA Contracts for Rx and Patient Data

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FDA says it will obtain prescription and patient-level drug use data from Wolters Kluwer through a multi-year contract.