The Safety of Newly Approved Medicines

作者: Michael A. Friedman , Janet Woodcock , Murray M. Lumpkin , Jeffrey E. Shuren , Arthur E. Hass

DOI: 10.1001/JAMA.281.18.1728

关键词:

摘要: The removal of 5 pharmaceuticals from the market in a 12-month period because unexpected adverse events raised concerns about adequacy drug review process at US Food and Drug Administration (FDA). Specifically, were improvements efficiency that significantly reduced FDA times. We have reviewed circumstances removals to determine whether there was any relationship increased efficiencies process. When removed drugs analyzed by date approval, no increase number taken off seen, demonstrating processing time not reason for cluster removals. conclude agency's procedures postmarketing surveillance system after has been marketed are currently adequate but must continually adjust future challenges.

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