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Keyword: pazdur

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  • WSJ: Pazdur's Cancer Rules - The FDA's oncology chief gets his revenge.

    07/06/2005 5:02:16 AM PDT · by OESY · 9 replies · 1,484+ views
    Wall Street Journal ^ | July 6, 2005 | Editorial
    ...FDA oncology drugs chief Richard Pazdur is the most important person in the U.S. government when it comes to cancer drugs, and he has never made a secret that he dislikes the accelerated approval process under which Iressa got the green light. Nor has he been shy about suggesting that the agency was railroaded in this drug's case. The truth is that Iressa-maker AstraZeneca simply refused to play by Dr. Pazdur's rules. In 2002 -- knowing it had plenty of data to qualify for accelerated approval -- the company rebuffed his requests for more trials and appealed directly to something...
  • WSJ: The FDA vs. Cancer Patients -- Drugs that save lives belong on the market

    05/19/2005 5:39:10 AM PDT · by OESY · 1 replies · 348+ views
    Wall Street Journal ^ | May 19, 2005 | Editorial
    ...Former FDA Commissioner Mark McClellan made some progress moving the agency to speed up the drug approval process. But he was pulled away to run Medicare, and agency bureaucrats have since been working feverishly to turn back the clock. The latest evidence of backsliding was a recent vote of the Oncologic Drugs Advisory Committee (ODAC) to recommend against approving Johnson & Johnson's leukemia drug Zarnestra.... This is a special shame because ODAC used to be a bastion of common sense, wherein clinicians who treat cancer patients would often buck FDA statisticians to approve new drugs. But ODAC is now chaired...