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Good Predictions: FDA Encouraged by Biomarker Progress

This article was originally published in RPM Report

Executive Summary

It's been just over a year since the Food & Drug Administration started down the Critical Path to drug development reform, and senior agency staffers are already exuding confidence that at least one of its first showcase projects will be a winner.

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Critical Collaborators

The Food & Drug Administration's dream of identifying a "critical path" to improve drug development productivity is one step closer to moving from rhetoric to reality. Three months after the official blessing from the Department of Health & Human Services for an effort by the C-Path Institute (in Tucson, Arizona) to create a consortium to validate preclinical toxicity test methods, C-Path has signed on nearly a dozen willing participants from big pharma.

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