Study of FDA review times for New Indication Approvals of Drugs and Biologics (2017 - 2019) finds FDA approved 107 drugs for 146 new indications [99 small molecules (68%) & 47 biologics (32%)]. Median regulatory review time was 6 mos (IQR, 6-10) https://t.co/3P6T4R4FCF https://t.co/avl65W3kvr
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Jun-30-2023


