The Rx Consultant
New Drugs 2019
The number of new drugs approved each year has increased significantly since 1990. Various expedited approval pathways such as Orphan Drug Status designation, Accelerated Approval, Fast-Track, Priority Reviews, and the use of surrogate endpoints in studies have reduced the FDA review time from more than 3 years in 1983 to less than 1 year in 2017. In 2019, the FDA’s Center for Drug Evaluation and Research approved 48 novel drugs – a decline from 59 in 2018.. Read More »

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