FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. The Draft Guidance covers charging in a clinical trial or in one of the expanded access settings and the differences between them. What’s new in the new Draft Guidance?

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

The Clinical Problem Solvers

DECEMBER 20, 2021

Appreciate how intergenerational trauma may surface amongst Asian-Americans, and how these intergenerational relationships may also offer fertile ground for generating understanding. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures.

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

FEBRUARY 15, 2024

Panelists Carmen Quatman and Katie Quatman-Yates have no relationships to disclose. Wait, first of all, what’s the incidence of calling EMS for falls over almost a decade, I think like 2007 to 2016, and what happens to people afterwards? All of these are factors that are on the individual level. Alex: The Wayback Machine.

Community 115

Community Transportation IT PCP 115

The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Applying a critical race lens to relationship-centered care in pregnancy and childbirth: An antidote to structural racism. Published April 20, 2016. See Reference 20 below for additional information. 2020;47(1):3-7.

Community 52

Community Patient-Centered Family Families 52

GeriPal

FEBRUARY 29, 2024

Widera and Smith have no relationships to disclose. Guest hosts Lynn Flint and Anne Kelly have no relationships to disclose. But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. ” Love it.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a cluster stepped wedge randomized trial? Long overdue.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77