After The Peak Of 2018’s US FDA Approval Record, 2019 Looks Like A Valley
FDA’s second half 2019 user fee calendar features almost 30 novel agents, but another record-breaking tally is out of reach.
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CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.
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.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker