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Guidance To Put More Combo Products Into Device Realm Due Out In Fall, FDA Commish Gottlieb Tells Congress

Executive Summary

A combination products guidance “to move more products into the device realm” will be released either at the end of this summer or in early fall, US FDA Commissioner Scott Gottlieb told lawmakers at a hearing. He also explained how new 21st Century Cures authority to hire biomedical scientists with very specific expertise will help the agency.

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