Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs

Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.

Breakthrough wave
Maybe CDER will catch the next wave of the breakthroughs. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US FDA’s marquee expedited review program, the breakthrough therapy designation, is likely to see less of an impact on novel approvals in 2023 than in past years, a Pink Sheet analysis indicates.

The Center for Drug Evaluation and Research has approved nine breakthrough-designated novel agents so far this year, or 21% of CDER’s 43 new molecular entity and novel biologic approvals in 2023

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