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

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.

The 11 products accounted for 22.9% of the 48 novel approvals in 2019 by the FDA’s Center for Drug Evaluation and Research. The second-highest percentage of six-month approvals was seen...