The Food & Drug Administration’s implementation of the new “breakthrough” therapy designation has had a pretty impressive start.
FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?
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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