CDER Reviewers Showcase Speed In 2019 With 11 Novel Drugs Approved Within Six Months
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.
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The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
The number of new active substances launched in their first market in 2019 dropped as 2018’s superlative performance gave way to something more usual.
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.