FDA Revises Its Letter for Non Approval of Drugs
New York Times 2008 July 10; p. C9
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CETUS Commentaries (FDA Members' Letter Regarding Policy on the Safety Approval of Recombinant DNA Proteins and Drugs) LaMonica, Filippo; Woodcock, Janet; Siegel, Jay P.; Zoon, Kathryn C.; Miller, Henry I. (1991-02)