FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

Clinic 59

Clinic Telehealth Provider Electronics 59

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

AUGUST 15, 2024

I had fun trying to make a danceable version with electronic drums for the audio-only podcast. We do a lot of clinical focused discussions. We shouldn’t be screening every older age and adult who comes into our clinic about these incidents for different reasons. Maybe we’ll get some BTS followers to subscribe to GeriPal?!?

Mental Health 116

Mental Health Community IT Screening 116

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. So we’re going to be talking about telemedicine, telehealth for people with serious illness. Brooke: So I think of telehealth as the umbrella. Now is the time to act, dear listeners!

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73