Clinical Trial Design, Precision Medicine Added To CDRH Science Priorities
US FDA's device center issued its third annual regulatory science priorities list, adding emphasis on clinical trial designs, and precision medicine and biomarkers, while dropping human-factors engineering from the list.
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FDA identified the device types that almost always need human factors, or usability, data included in premarket submissions in a draft guidance posted in conjunction with final guidelines with broader human factors testing recommendations.
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Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.