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A Critical Test for FDA's Critical Path Initiative

This article was originally published in RPM Report

Executive Summary

FDA wants to reverse the deline in NDA approvals; the agency may have a key ally at a new center in Arizona.

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FDA is joining in the push for new tuberculosis treatments, with Commissioner Hamburg lending support for a renewed development effort. The challenge is to translate podium appearances into changes that will make for a more attractive development pathway. The primary goal is to find a way to study multi-drug regimens, including regimens with more than one investigational compound. FDA is engaging on that thorny regulatory issue.

TB Drug Development: An Attractive Public Health Project for FDA

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