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US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18

 
• By Bridget Silverman

Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

FDA Raising The Bar
CDER’S APPROVAL LIFT IN 2021 WAS EVEN MORE WEIGHTED TOWARD PRIORITY REVIEWS THAN USUAL. • Source: Alamy

Despite unprecedented events in public health and politics, the US Food and Drug Administration’s 2021 story about novel agent approvals hit some familiar (but nonetheless impressive) notes: another year of novel drug approval counts that would have been unfathomable in the first decade of the 2000s.

The FDA’s drug and biologics centers approved a combined total of 60 novel agents, just the second time the combined total reached that high – after the annus mirabilis of 2018, when the centers combined for 65 novel agents – and only the third time the Center for

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