FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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The Clinical Problem Solvers

MARCH 14, 2025

Calac March 14, 2025 Summary: In this first half of a two-part series, we discuss the growing rates of suicide amongst child and adolescent populations in the United States, with a focus on historically underserved groups. They are often the first interface for patients experiencing mental health crises, not academic medical centers.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. To request an FEI Number, laboratories will need to provide a long list of identifying information to FDA via email ( feiportal@fda.hhs.gov ) ( see slide 23 of the FDA’s presentation for the complete list).

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FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” and remote or wearable patient monitoring devices (e.g.,

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

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FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

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Medical Xpress

JUNE 16, 2025

Share Tweet Share Email Home Psychology & Psychiatry Home Addiction June 16, 2025 The GIST Texas invests $50M in psychedelic drug research to treat addiction by I. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. More information: ScienceDirect has more on ibogaine.

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Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. All rights reserved.

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Medical Xpress

JUNE 16, 2025

More information: Po-Ting Yeh et al, Discrete photoentrainment of mammalian central clock is regulated by bi-stable dynamic network in the suprachiasmatic nucleus, Nature Communications (2025). The content is provided for information purposes only.

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FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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GeriPal

JUNE 19, 2025

Knowing that the community is really underrepresented in sort of our knowledge, what we do, how we provide care that’s truly inclusive and welcoming. And this is for all of us, that when we’re going into this space of providing inclusive and affirming care, it really starts out with humility, because there’s a lot to learn.

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

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GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? 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.

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Medical Xpress

JUNE 7, 2025

12 Tweet Share Email Home HIV & AIDS June 7, 2025 The GIST Long-lasting HIV prevention shot headed toward approval by I. © 2025 HealthDay. Citation : Long-lasting HIV prevention shot headed toward approval (2025, June 7) retrieved 9 June 2025 from [link] This document is subject to copyright. All rights reserved.

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GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). I’m hearing dementia patients or patients with dementia. Eric 09:15 And then who were the patients just with dementia or were they. Is that right?

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Medical Xpress

JUNE 8, 2025

million surfs carried out each year in Victoria, researchers estimate that this could equate to more than 70,000 assists and almost 25,500 cases of first-aid provided by surfers annually. This is the first study to quantify surfer beach -safety actions, providing real-world implications of their impact. With more than 6.3

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Medical Xpress

JUNE 23, 2025

Enzymes provide the body with instructions for what it needs to do, and when people lose energy and water, biochemical systems in the body start to fail, Wood says. Provided by Northeastern University This story is republished courtesy of Northeastern Global News news.northeastern.edu. Similarly, you need to have energy.

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