FDA sped progress for most of 2020's novel drugs

RAPS

14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals.

Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 2019’s 48 approvals but fell short of the 59 approved in 2018.

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Michael Wonder

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Michael Wonder

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Medicine , Regulation , Review , Timelines