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FDA/IoM “Uncertainty” Conference Adds Uncertainty to Biogen Growth Plans For Tysabri

This article was originally published in RPM Report

Executive Summary

An FDA/Institute of Medicine workshop on characterizing and communicating the uncertainty inherent in risk/benefit decisions touched on an important topic for every sponsor. But two “case studies” included points a very particular interest to Biogen Idec, and to sponsors in the COPD class.

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