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FDA is failing to inspect drug and device makers, government reports say

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39482.413137.DB (Published 07 February 2008) Cite this as: BMJ 2008;336:297
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration has not met its legal requirements to inspect US and foreign medical drug and device manufacturers, and it has not provided effective oversight of domestic and imported food, according to two reports by the General Accountability Office, the independent investigative arm of Congress.

    The reports, both released on 29 January, said that the FDA’s science base, scientific workforce, and information technology infrastructure were weak and inadequate.

    In November the FDA’s subcommittee on science and technology found “substantial weaknesses across the agency.”

    At a hearing of the subcommittee on oversight …

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