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Keyword: eloxatin

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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...