Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

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CDER’s PERFORMANCE HEADS BACK TO THE MEAN, WHILE CBER STAYS ABOVE AVERAGE. • Source: Shutterstock

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