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Tag: CBER approvals

CBER approvals

Regulatory/FDA

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

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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Regulatory/FDA

CDER Approves 27 Novel Drugs in First Half of 2021

CDER Approves 27 Novel Drugs in First Half of 2021

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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