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Compliance $$$ Settlements a New FDA Funding Source?

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Washington commentator Robert F. Steeves notes the rising sums being recovered under the False Claims Act from drug companies and ...

CRO Association Urges Increased Foreign Inspection Appropriations

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Clinical researchers urge Congress to increase FDA appropriations to help it inspect more foreign clinical trial sites.

B. Braun Medical Recalls 'Tainted' Heparin

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B. Braun Medical recalls seven lots of heparin injection products after being informed that its active pharmaceutical ingredient c...

Amira Pharma Begin Trial with Novel LPA1 Antagonist

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Amira Pharmaceuticals begins a Phase 1 clinical study with AM152, a novel LPA1 antagonist being evaluated for treating fibrotic di...

FDA OKs BMS Sprycel for Additional Leukemia Indication

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FDA approves Bristol-Myers Squibbs Sprycel (dasatinib) for treating newly diagnosed Philadelphia chromosome positive chronic phase...

Institute of Medicine to Study 'omics' Technologies for Trials

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The Institute of Medicine says it will convene a special committee to review published literature to identify appropriate evaluati...

FDA Clears ArthroCares Suture Implant System

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FDA clears ArthroCare Corp.s Spartan PEEK Suture Implant System for use in fixation of soft tissue to bone.

Animal Drug Sponsor Changed to Land O Lakes Purina

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Federal Register Final rule: FDA amends the animal drug regulations to change a sponsor for a supplement block containing monensin...

Panel to Discuss Replication Competent Retrovirus/Lentivirus

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/19 to discuss testing replicatio...

Participants Sought in Selecting Device Panel Reps

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Federal Register Notice: FDA seeks participants in selecting nonvoting industry representatives to serve on the National Mammograp...