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Digital Health FDA Regulation

Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says

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Executive Summary

Under new platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate premarket device review.
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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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