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BioPharmaceutical Medical Device Regulation

From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age At FDA

This article was originally published in RPM Report

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Executive Summary

An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.

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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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