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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.

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