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Legislation introduced to create a new drug safety office at the FDA

BMJ 2005; 330 doi: (Published 05 May 2005) Cite this as: BMJ 2005;330:1044
  1. Jeanne Lenzer
  1. New York

    After a year of controversy at the US Food and Drug Administration over drug safety, Senators Chuck Grassley (Republican, Iowa) and Chris Dodd (Democrat, Connecticut), introduced legislation last week to establish an independent office of drug safety at the agency.

    The Food and Drug Administration Safety Act of 2005, if passed, will establish a Center for Post-market Drug Evaluation and Research. Its director would report directly to the FDA commissioner. Currently, the FDA's Office of Drug Safety serves in a consultative role to the Office of New Drugs.

    David Graham, the FDA scientist who …

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