FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

FEBRUARY 6, 2025

We now have biomarkers that can reasonably approximate the degree of amyloid build-up in the brain with a simple blood test. We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. I just had lab tests done. Nate, welcome back to the GeriPal Podcast.

Primary Care 97

Primary Care Diagnosis Screening IT 97

GeriPal

FEBRUARY 9, 2023

Alex: We are delighted to welcome Amber Barnato, who’s a palliative care physician and health service researcher, and she’s director of the Dartmouth Institute for Health Policy and Clinical Practice. Amber: Well, simulation is pretending, so I think of the way I use simulation is in trying to simulate clinical care.

Patient-Centered 112

Patient-Centered Patients IT Healthcare 112