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  • From the Editor: Isn t It Time to Update cGMPs?
    Agnes Shanley, Editor in Chief Even if you re on the right track, you ll get run over if you just sit there. the U.S. Food and Drug Administration (FDA) celebrated its hundredth anniversary quietly, with commemorative programs and a retrospective on its Web site. In the post-Vioxx, FDA-bashing
  • The Art of Firing People
    Chapter Three of "The Whistleblower Confessions of a Healthcare Hitman " is hereby reprinted with permission of Soft Skull Press, Brooklyn, N.Y. AS THE APRIL 2003 Pfizer takeover date rapidly approached, some more Pharmacia employees received job offers from the new organization, many of whom
  • Risk-Based cGMPs: A Progress Report
    It's been one year since the Food and Drug Administration (FDA) announced its aggressive two-year overhaul of current good manufacturing practices (cGMPs) based on risk analysis. And in a September 3 press conference, FDA leaders marked the midpoint of the initiative with a flurry of announcements

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