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FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?

This article was originally published in RPM Report

Executive Summary

Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?

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