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Personalized Medicine Review Pathway Cancer

Companion Diagnostics: US FDA Streamlines Risk Determinations In Oncology

  • Analysis

Executive Summary

Information about investigational drug and in vitro diagnostic may be submitted in single IND to agency's drugs or biologics centers, eliminating need for separate submission to devices center; new process should give greater therapeutic context to decisions of whether the IVD is considered a significant risk.

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Personalized Medicine Review Pathway Cancer
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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