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. Diversifying your mental health outreach goes hand in hand with diversifying your providers. March 14, 2025.

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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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Physician's Practice

JUNE 25, 2025

June 25, 2025 By Neil Baum, MD Fact checked by Keith A. These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices.

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FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

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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. Price, M.D.

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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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FDA Law Blog

JUNE 21, 2023

Background – Strategic Priority to Advance Health Equity In CDRH’s 2022-2025 Strategic Priorities , “Advance Health Equity” is listed as one of the three strategic priorities along with “Promote a Modern and Diverse Workforce” and “Enhance Organizational Agility and Resilience.” telemedicine and telehealth solutions (e.g.,

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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. ” Abstract/Full Text Copyright © 2025 HealthDay. .

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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

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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FDA Law Blog

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. 806) and Complaint Files (21 C.F.R.

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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

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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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. We weren’t randomizing providers or patients. Corita 09:39 Yeah, so we used the electronic health record, I think, in support. This is not why I went into emergency medicine.

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FDA Law Blog

JUNE 10, 2025

23,711 (June 4, 2025). 23,483 (June 3, 2025). One commenter, without providing details, asserted that the chemical may have uses in the medical field. Public comments must be submitted electronically or postmarked on or before July 3, 2025. 23,477 (June 3, 2025).

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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

And so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. So we have to collect what information we have available from Health Information exchange and electronic health records. What’s in the electronic health record?

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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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FDA Law Blog

FEBRUARY 5, 2025

Clissold During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of the FD&C Act to adopt tobacco product standards.

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