What emerging trends in the FDA’s most coveted designations might tell us

Marked shifts in the pursuit and grant of high-order designations raise fascinating questions. What factors might be driving the sharp downturns in CDER breakthrough designations? And does the sharp post-pandemic upturn in high-order designations by CBER represent a shifting of enthusiasm in favor of advanced therapies? This report, analyzing recent data from the FDA, gives critical insights into market shifts in high-order designations and what it might mean for drug developers.

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