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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). Study visits can be conducted using telehealth visits if in-person interaction is not necessary. Trial personnel can also be sent to participant’s homes.

Clinic 59
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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law Blog

telemedicine and telehealth solutions (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., We previously blogged on the draft guidance here. pregnancy tests, blood glucose monitoring systems, COVID-19 tests, etc.),

Medical 45