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CDER Reviewers Showcase Speed In 2019 With 11 Novel Drugs Approved Within Six Months

 
• By Michael Cipriano

Median review time held steady in 2019, but the percentage of NDAs the US FDA approved within six months jumped compared to recent years, a performance upswing all the more impressive because of the relatively high number of applications involved.

Pink Sheet Perspectives 2019 to 2020

The US Food and Drug Administration's drug center cleared 11 novel agents in 2019 with a review time of six months or less. The batch of approvals with this six-month metric was the highest seen in at least the past five calendar years by both number and share of total drug center approvals.

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