The Motivated MD

OCTOBER 10, 2024

How, then, can any physician find the time to research individual companies and make educated decisions on which publicly traded businesses are undervalued? Instead of investing in individual stocks, why not buy all the most economically impactful stocks in a proportion that reflects an index of the market? We simply cannot.

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FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

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Manufacturing Management Specialization Provider 71

FDA Law Blog

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The public may harbor similar doubts, leading prosecutors to avoid putting Park cases before juries.

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. This week, we are tackling all things related to lifestyle creep. These posts may contain affiliate links.

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Finance Insurance Individual IT 52

Aspiring Minority Doctor

JUNE 18, 2023

Additionally, this past week alone, a large number of former medical students who rotated with me during my intern year graduated from the shorter duration residencies in Internal Medicine, Family Medicine, etc and are now getting to do what they set out to do. When I was a premedical student, all I wanted to do was be a medical student.

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Medical Student Medical IT Internal Medicine 52

FDA Law Blog

JULY 12, 2022

On June 30, individuals with access to the CCP (i.e., The email also states that the ability to submit completely electronically will first be offered to individuals with CCP accounts so that CDRH can assess the platform’s performance. the only submission type currently trackable via the CCP).

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GeriPal

MAY 19, 2022

As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. Drew: I’ve published a draft version of it on the blog. But I just don’t expect my medical students, residents and generalist colleagues to do that and to have that. It’s compacted.

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FDA Law Blog

FEBRUARY 18, 2025

The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing. Only then should an expert delve into the application of those fundamental principles to the specifics of a patients medical file or dispensing history.

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Government Specialization Patients IT 69

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

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Hospital Manufacturing Specialization Medical 52

FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis.

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). There should also be a plan in place for responding to adverse events, including how participants are expected to seek medical assistance locally when necessary.

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). 3, 2020).

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 7, 2025

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. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Aspiring Minority Doctor

FEBRUARY 7, 2023

My original flight was changed by the airline a couple of months prior, so I specifically added the Atlanta layover so that I could have lunch with one of my dearest friends from medical school, but she absolutely surprised me with the best birthday gift ever! It made me feel so special and loved. It was such a beautiful gift.

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IT Medical Mental Health Patients 52

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. After similar explorations in gastroenterology , hematology and medical oncology , ABIM announced the development of several new focused LKAs planned for launch in those areas in 2026.

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GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

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IT Patient-Centered Illness Education 127

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". Food has the power to regenerate the new you!

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GeriPal

AUGUST 31, 2023

He studies the mental health system in the ways in which it has failed children and adolescents, and he writes about his experience with cancer in a blog, the Billgardner.substack.com, Billgardner, one word. ” Somebody in the comments on their blog response said, “Did you check the date? We could have talked for hours!

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics. And you’re thinking, hey!

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Consulting Individual Families Family 59

GeriPal

APRIL 14, 2022

We got some really special guests with us. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And so that lends it properties of being a pretty strong analgesic and it lends its special properties for safety, from a safety profile.

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Illness Patient-Centered IT Patients 103

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 30, 2023

We’ve also love to hear from you on twitter and facebook your own experiences writing for the medical world (and please include links!) And so, it’s about going live on stage in the medical audience, and everything from the whiteboard in the surgery room saying, “Here’s the lineup. This is Eric Widera.

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IT Patient-Centered Patients Healthcare 96

GeriPal

SEPTEMBER 22, 2022

Alex: Today, we’re delighted to welcome Josh Briscoe, who is assistant professor of medicine and psychiatry at Duke, and a palliative care physician at the Durham VA Medical Center. All these studies in this fringe… We want the special key. Most of serious illness is not medical decisions. Eric: Yeah.

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Illness IT Patient-Centered Patients 102

GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). This week we turn our attention to the inmates. This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time.

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GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. Eric: And for our audience, if they can’t tell, there’s a theme here. Eric: Yeah.

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IT Healthcare Professional Healthcare Transportation 106

FDA Law Blog

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry.

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Manufacturing IT Individual Provider 59

FDA Law Blog

NOVEMBER 8, 2023

Koblitz & Philip Won — The first anniversary is always special. For those who are unfamiliar with the rule, let us briefly explore its history across three different administrations (see our previous blogs: here , here , and here ). By Jeffrey N. Gibbs & Sara W. In some measurable ways, the rule has been a success.

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Utilities IT Engineering Appointment 64