CDER's Novel Approvals In 2018 Show Remarkable Review Consistency
Executive SummaryYears of regulatory fine-tuning culminated in record low average time to approval of 9.9 months for novel agents at US FDA’s drug center.
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US FDA approved just six new molecular entities in the first quarter of 2019, which seems like quite a letdown after a record-setting year in 2018. But don’t despair: the pattern of NME approvals was back-loaded a year ago – and should be again this year.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.