FDA – 2019 in review

MAESTrO Database

8 January 2020 - Analysis of NDA approval timelines for 2019.

The FDA’s Center for Drug Evaluation and Research approved 48 novel drugs in 2019.  While this value is above the 10 year (2010-2018) mean of 37, it is below 2018's record tally of 59.

For the 48 novel drugs approved in 2019, the mean value for the period from the date of the initial submission to the date of FDA approval is 441 days. While most of the 48 novel drugs approved by the FDA in 2019 after one submission, a small number required a resubmission.  The corresponding median value (243 days) was much lower than the mean.

While the mean value for 2018 (319 days) is much lower, the median value is little changed (245 days).

Looking for more insights? Contact us for a more detailed analysis of FDA NDA approvals for 2019.

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Regulation , Timelines