Tag: approval rate

approval rate

Regulatory/FDA

CDER Novel Drug Approvals Set Record Pace in First Quarter

CDER Novel Drug Approvals Set Record Pace in First Quarter

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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