DATA GRAPHICS | Data Byte
Historically for vaccines, use of accelerated approval could soon shift at FDA’s CBER
Of 33 BLAs approved via the pathway, 20 are for vaccines. Approvals for cancer, rare disease have been on the rise
June 5, 2025 12:02 AM UTC
An analysis of accelerated approvals granted by FDA’s Center for Biologics Evaluation and Research suggests ways that narrowing or widening use of the pathway could change drug development priorities and impact public health.
The data also show dramatic differences between the use of accelerated approval at CBER and at the Center for Drug Evaluation and Research (CDER). ...
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