CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

According to a report released this week describing CDER’s approval of 55 novel drugs in 2023, the agency failed to meet its goal dates under the Prescription Drug User Fee Act (PDUFA) Commitment Letter for 11% of applications – a record high. Here, AgencyIQ analyzes the root causes of these delays, and whether a trend could emerge in the coming years.

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