FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

Finance 52

Finance Individual Management IT 52

The Motivated MD

DECEMBER 18, 2024

Infuse your budget, buy a new electronic, place it in cryptocurrency, whatever. If you can control your evolving income, you will find yourself actively managing budgetary increases, tackling your financial goals, and rewarding yourself regularly, all while preventing the insidious form of lifestyle inflation.

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Finance Insurance Individual IT 52

PEMBlog

AUGUST 30, 2023

Special thanks to Todd Florin, MD, MSCE who contributed to this post – he is also an expert on respiratory and infectious emergencies. Research suggests most CXRs are performed because ED clinicians (and many parents) are concerned for the possibility of missing pneumonia or another diagnosis requiring specific management.

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Asthma Electronics Utilities Clinical Practice 52

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them.

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FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them.

Management 40

Management Consulting Provider Physicals 40

Permanente Medicine

MAY 20, 2025

Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. Innovation thrives when you get multiple diverse perspectives.”

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Patient-Centered Patients IT Medical 52

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

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Screening Primary Care Patient-Centered IT 120

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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Physician's Practice

JUNE 20, 2025

For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt. Successful practices have found ways to work around the loss of productivity and ultimately made Electronic Medical Records (EMRs) work effectively in their practices.

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Management Patient-Centered Appointment Patients 52

The Motivated MD

NOVEMBER 26, 2024

It shows that you can manage a large debt and make payments regularly without defaulting. Use the rules provided above to determine what is right for you. I am in no way, shape, or form a financial professional, nor does this site provide formalized financial advice. Paying down a mortgage is also good for your credit score.

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Finance Insurance Individual Medical Advice 52

FDA Law Blog

SEPTEMBER 26, 2022

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4 through alternative or streamlined mechanisms. Section 21 C.F.R Section 21 C.F.R Section 21 C.F.R

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Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission.

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Mental Health IT Medical Specialization 52

FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families.

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Illness Hospital Patient-Centered Patients 111

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. You can contact her via email at egroopman@childrensnational.org.

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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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GeriPal

SEPTEMBER 7, 2023

So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? Do you worry about that? Well, I do it personally.

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GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Why do so many (most, all??)

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GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it.

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GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ). Alex: Yeah.

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GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. Sydney 22:01 Well, it’s what’s in the electronic health record.

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GeriPal

JULY 20, 2023

And the thought of a huge number of our patients who had really come to rely on being able to do their visits from home or from a place that was close to home and getting medications that they’ve really come to rely on for symptom management was just really kind of terrifying for us and for them. What did we learn during the pandemic?

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