Issue 4 - The Cancer Letter

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Vol.

35

No.

4

January 30, 2009Jan 30, 2009

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Special Report: KRAS Finding Changes Oncology Practice But Poses Profound Regulatory Dilemma

FDA Concerned About Data-Dredging In Drug-Diagnostic Applications

Government Offers Two Approval Standards For Assays: CLIA, FDA

FDA Ponders Standards For “Retrospective Prospective” Studies

ODAC Discussion: NCI’s Richard Simon Cautions About Rules Of Thumb

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