The accelerated approval pathway's impact speaks for itself
Without FDA's accelerated approval pathway, nearly two-thirds of new medicines developed in the last 20 years would have failed to reach patients. More than 80% of these medicines treat rare conditions. And with FDA-approved treatments for only 5% of the estimated 7,000 to 10,000 rare diseases, pathways like accelerated approval are vital to encourage rare disease drug development in the biopharmaceutical industry. Read new findings on the impact of the accelerated approval pathway here.
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