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 On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.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. So, you need to decide.

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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.” By Philip Won & McKenzie E.

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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. The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA).

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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). This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day.

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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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GeriPal

JUNE 19, 2025

Eric and I remember him from that time and he’s now at the University of Nevada, Las Vegas, where he is associate professor in the department of social and behavioral health. Jace, welcome to the GeriPal Podcast. Jace 00:37 Thank you so much, Alex and Eric, it’s nice to be here with you. Eric 01:21 Why’d you choose this song?

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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

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. I went into emergency medicine to act. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter?

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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. 21 U.S.C. § 842(a)(11). 21 U.S.C. § DEA published the original Special Surveillance in May 1999. Designation of Propionyl Chloride as a List I Chemical, 90 Fed.

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GeriPal

MARCH 27, 2025

We are delighted to welcome Jennifer Wolf f , who is a health services researcher and gerontologist and professor at Johns Hopkins. Jennifer, welcome to the GeriPal Podcast. Jennifer 00:28 It’s great to be here. But before we dive into the study and the implications it has for the practice that we do, I believe someone has a song request.

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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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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. Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." Youve lost the ability to dissipate heat," he says.

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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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