April 6, 2021 – The FDA’s Center for Drug Evaluation and Research (CDER) approved 14 new molecular entities (NMEs) in the first quarter—up from 11 in the same span in 2020. According to AgencyIQ, this is a record for any first quarter in FDA history. Taken together with the 53 NMEs approved in 2020 (story […]
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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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