publication date: Dec. 1, 2010

In this issue: 

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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