FDA/Center for Drug Evaluation and Research (CDER) to Genentech, Inc. - Letter

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...Proposal to Withdraw Marketing Approval; Notice of Oppotunity for A Hearing

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FDA/Center for Drug Evaluation and Research (CDER) to Genentech, Inc. - Letter

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Abstract: ...Proposal to Withdraw Marketing Approval; Notice of Oppotunity for A Hearing
Authors: cder
 

 
 
Comment Period Closed
ID: FDA-2010-N-0621-0001

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Date Posted: Dec 16, 2010
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re: t-dm1 rtf letter. If trial data from 2nd her2+ mbc phaseII trial justified a 30 center extension trial, it's hard too understand FDA refused to consider to...
Dr. Karen Midthun, the F.D.A. officer who will oversee the hearing, said she would not add breast cancer experts to the committee. “We must face the reality...

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