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Direct Primary Care - Role for the Future of Healthcare

The Direct Doctors Difference

Looking back to 2014, when we began, there were less than 100. The strength also comes from a group of physicians who want something more and something better - improved work-life balance, return of joy to practicing medicine, and a renewal of the pure physician-patient relationship where the doctor knows his or her patient well.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

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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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Walsh & Sophia R. Mallory , 988 F.3d

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Not “burnout,” not moral injury—human rights violations

Pamela Wible MD

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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Episode 322: Antiracism in Medicine – Episode 24 – Leveraging Narrative Medicine to Cultivate Antiracist Praxis

The Clinical Problem Solvers

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Episode Learning Objectives After listening to this episode, learners will be able to: Illustrate the relationship between narrative medicine and healing relationships.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Natal alienation is, in part, the under-structure of the wider Medical-Industrial Complex and the gratuitous violence that fat, Black, trans folks experience. is rooted in anti-Blackness.