Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly […]
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July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]
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Aug. 20, 2020 – The Food and Drug Administration’s (FDA’s) ability to approve new drugs while juggling new responsibilities during the COVID-19 pandemic appears to be exceeding expectations, with the agency approving 36 novel drugs to date in 2020, an increase from the 24 new molecular entities (NMEs) approved by this date in 2019 (with […]
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