FDA Alert RE: Levemir

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

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FDA Imposes Restrictions on Coast IRB due to Violations

The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.

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FINAL RULE ISSUED FOR PATIENT SAFETY ORGANIZATIONS

The U.S. Department of Health and Human Services has issued a final rule for Patient Safety Organizations (PSOs).

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