FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Clinic Relationship Provider IT 64

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.

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Patients Patient-Centered Clinic Community 52

Pamela Wible MD

JUNE 20, 2025

Characterized by cynicism, exhaustion, and reduced job satisfaction, physician burnout can lead to devastating personal and professional consequences, including strained relationships, substance abuse, early retirement, and even suicide. It’s a growing crisis affecting over half of all doctors in the U.S., They’re suffering from moral injury.

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Medical Student Diagnosis Physicals Medical 246

The Clinical Problem Solvers

MARCH 4, 2024

Episode Learning Objectives After listening to this episode, learners will be able to: Illustrate the relationship between narrative medicine and healing relationships. What the term gestures towards is the centering of the ‘story’ in healing relationships. The show notes for this episode were written by Sudarshan Krishnamurthy.

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Community Education Patient-Centered Relationship 52

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. All of this contributes to various mental health challenges that are consistent with surveillance in not only a wider police-state but also the patient-physician relationship.

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Community Manufacturing Patients Medical 52

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is.

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Families IT Family Diagnosis 102

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. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC.

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Patient-Centered IT Hospital Patients 77