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Running Late: FDA Review Timelines Lengthen For New Product Applications

This article was originally published in RPM Report

Executive Summary

FDA is missing more new drug review deadlines: at least seven in the first eight months of this year. The experiences of those delayed applications indicate some interesting ways to interpret what it means when a user fee date comes and goes without an FDA decision. One clear observation: the longer a sponsor has to wait after the user fee deadline, the worse the likely result.

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