FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later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

Clinic Telehealth Provider Electronics 59

FDA Law Blog

JUNE 21, 2023

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., For those who are interested, comments should be submitted to the docket ( FDA-2023-N-1956 ) by August 30, 2023.

Medical 45

Medical Patients Healthcare Electronics 45

GeriPal

JULY 20, 2023

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.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73