Oncology Biomarker Initiative Will Adapt Existing Clinical Trials For Validation
This article was originally published in The Pink Sheet Daily
Executive Summary
First project under initiative by FDA, NCI and CMS will evaluate use of PET scans to predict early response in non-Hodgkin’s lymphoma patients.
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The public/private partnership is administered by NIH and includes FDA, CMS, patient efficacy groups and industry.
Critical Path Should Follow GMP Model, FDA’s Woodcock Says
To avoid public pushback, the Critical Path initiative should focus on science, not regulatory overhauls, Woodcock tells DIA.
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