FDA faster than global peers at approving new drugs


16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the US FDA has reclaimed its position as the fastest major regulator for approving new drugs and biologics.

According to the report, FDA spent a median 243 days to approve products with a new active substance (NAS) in 2017, 90 days faster than its closest peer, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), which took a median 333 days.

While FDA has typically taken less time to approve NASs than other prominent regulators over the last decade, efforts by Japan to speed drug evaluations led PMDA to edge FDA out for quickest reviews from 2014-2016.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , US , Timelines , Canada , Japan