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. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Physician's Practice

JUNE 25, 2025

June 25, 2025 By Neil Baum, MD Fact checked by Keith A. Reynolds June 24th 2025 Article Thoughtful design in medical practices enhance patient experience, boost staff productivity, and improve online reviews without major renovations. of AIMPA Austin Littrell June 23rd 2025 Podcast Paul Berggreen, M.D.,

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FDA Law Blog

SEPTEMBER 22, 2024

This process includes requesting an ESG (electronic submission gateway) account, submitting a “test MDR submission”, and sending FDA a copy of the “pass” acknowledgement (AcK3) to the eMDR help desk to request approval for a production account, all of which can take some time before the laboratory is able to submit MDR electronically.

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Physician's Practice

JUNE 19, 2025

Layer onto that the growing bring-your-own-device culture: allowing employees to sync personal smartphones with the electronic health record can “raise privacy concerns” and blur the line between work and off-hours browsing, warns a HIPAA BYOD briefing. Austin Littrell May 19th 2025 Podcast Jeffrey A. Singer, M.D. Singer, M.D.,

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 On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

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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. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2.

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Permanente Medicine

JUNE 25, 2025

When a patient visits any physician for any reason, they are reminded that it is time for their screening, flagged by our integrated electronic health record. A third of U.S. But at its core, this program is about communicating with patients and understanding their needs.

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Permanente Medicine

APRIL 29, 2025

The electronic health record system automatically prompts care teams to schedule patients for health screenings. The Kaiser Permanente study will be presented at the 2025 Digestive Disease Week meeting on May 3. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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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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Medical Xpress

JUNE 8, 2025

Citation : Preemies receive sucrose for pain relief—new research shows it doesnt stop long-term impacts on development (2025, June 8) retrieved 9 June 2025 from [link] This document is subject to copyright. It has become the worldwide standard of care for acute neonatal pain, but it doesnt seem to be helping in the long term.

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FDA Law Blog

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. 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. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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FDA Law Blog

JUNE 10, 2025

23,711 (June 4, 2025). 23,483 (June 3, 2025). DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. 21 U.S.C. §

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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

More information: Buly A Cardak et al, The safety actions of surfers in Victoria, Australia: Assessing the impact of water safety and first aid training, Safety Science (2025). The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. DOI: 10.1016/j.ssci.2025.106914

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Medical Xpress

JUNE 23, 2025

Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." Heat stroke is when sweating and other compensatory systems that remove heat from the body no longer function, Wood says. If there is any sweat on the skin, it dissipates and the skin becomes very dry, 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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