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FDA Drug Safety Regulation

'Huge Need' For Neurotoxicity Biomarkers In Drug Development, FDA's Woodcock Says

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Executive Summary

"Perfect storm" makes it difficult to develop safety biomarkers, Woodcock tells US FDA workshop, citing lack of body charged with developing them and greater evidence required for their qualification.

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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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