US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18
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.
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Our infographic shows the various routes that the 60 novel agents took to approval, from Real-Time Oncology Review to Qualified Infectious Disease Product designation.
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).
News and highlights from the Pink Sheet’s US FDA Performance Tracker