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US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics

 
• By Bridget Silverman

FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.

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While not a high-water mark, US FDA's 2020 approval total is still one for the history books • Source: Shutterstock

In a world without the COVID-19 pandemic, the FDA’s total of more than 50 novel drugs and biologics approved in 2020 would be another notable year in a string of the most productive years in modern agency history. In light of the restrictions and competing pressures assailing the agency during the COVID-19 pandemic, the healthy class of 2020 novel approvals is nothing short of remarkable.

The Center for Drug Evaluation and Research approved 53 new molecular entities and novel biologics in 2020, including the first (and to date only) full approval under the regular new drug application pathway for a COVID-19

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