Jumpstarting U.S. Device Trials? FDA Makes Effort In New Draft Guidelines

By Rebecca Kern, Jessica Bylander / Email the Authors / “The Gray Sheet” Nov. 14, 2011, Vol. 37, No. 46
Regulatory / Word Count: 1142 / Article # 01111114010

Executive Summary

New FDA guidances aim to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.

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Jumpstarting U.S. Device Trials? FDA Makes Effort In New Draft Guidelines

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