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.
Download (PDF 496K)
To access this members-only content, please log in.
Institutional subscribers, please log in with your IP
If you're not a subscriber why not join today?
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.