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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59
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Anti-Asian Hate: Russell Jeung, Lingsheng Li, & Jessica Eng

GeriPal

I had fun trying to make a danceable version with electronic drums for the audio-only podcast. Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. And also the language concordance has been an issue, I think, for both in person and telehealth care.

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

This DEA is taking 6-months to consider how to move forward vis a vis restrictions and requirements for telehealth in a post-pandemic world. See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Brooke: So I think of telehealth as the umbrella. Eric: Yeah.