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US FDA’s 2021 Novel Approvals: A Closer Look

 
• By Bridget Silverman

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.

Workers on tug boat overlooking ship
THE LARGE VOLUME OF APPLICATIONS SENT TO FDA HAS ADDED TO THE CHALLENGE OF NAVIGATING THE PANDEMIC. • Source: Alamy

Earlier this week, the Pink Sheet offered some historical context around the 60 novel agents approved by the US Food and Drug Administration in 2021, the second biggest total in contemporary agency history. (Also see "US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18" - Pink Sheet, 2 January, 2022.)

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• By Neena Brizmohun

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

More from Product Reviews

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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