FDA’s Benefit/Risk Framework Will Focus On Communication, Not Quantification

This article was originally published in The Pink Sheet Daily

20 Jun 2012
News

M. Nielsen Hobbs @PinkSheetHobbs nielsen.hobbs@informa.com

Executive Summary

CDER Director Woodcock tells BIO’s International Conference that the agency’s effort to formalize its approach to risk/benefit assessments will produce better sharing of approval conundrums, but not necessarily a mathematical solution to those problems.

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FDA’s Benefit/Risk Framework Will Focus On Communication, Not Quantification

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Executive Summary

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