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The U.S. Food and Drug Administration has a proposed a rule that would allow reclassification of devices via an administrative order published in the Federal Register.

The U.S. Food and Drug Administration's Center for Devices and Radiological Health released its Medical Device Recall Report for FY 2003 to FY 2012, showing device recalls have nearly doubled in the past 10 years.

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The U.S. Food and Drug Administration has approved Xolair (omalizumab) to treat chronic idiopathic urticaria, a form of chronic hives, according to a news release.

The U.S. Food and Drug Administration has approved Piramal Imaging's Neuraceq, a positron emission tomography imaging agent to aid in diagnosing dementia, according to a company news release.

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