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BioPharmaceutical

Bayesian Trial Submissions Could Consume More FDA Resources, CDRH Says

This article was originally published in The Pink Sheet Daily

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Executive Summary

Device center statisticians currently spend at most 5%-10% of their time and effort evaluating Bayesian statistical analyses in premarket submissions, but the center continues to ramp up its resources to deal with a potential influx relying on the advanced technique.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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