Companion Diagnostics: US FDA Streamlines Risk Determinations In Oncology

15 Apr 2018
Analysis

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

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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United States

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BioPharmaceutical

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Companion Diagnostics: US FDA Streamlines Risk Determinations In Oncology

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