Tag: novel drug approvals

novel drug 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

Will FDA’s Budget and Drug Approval Momentum Continue Past 2020?

Will FDA’s Budget and Drug Approval Momentum Continue Past 2020?

Feb. 17, 2020 — The Food and Drug Administration (FDA) began 2020 with continued momentum on drug approvals, a significant budget increase and a newly-confirmed Commissioner — Dr. Stephen Hahn – who has not yet presented his priorities for ongoing operations and new initiatives. But President Trump’s fiscal 2021 budget—released Feb. 10 – raises some […]

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