Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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Physicians Alliance of Connecticut

MAY 27, 2025

Healthcare administrative assistants manage crucial administrative tasks in medical offices. Their role improves the patient experience and helps doctors, nurses, and other providers work more efficiently. As a healthcare administrative assistant, your day-to-day tasks may vary depending on the needs of the medical office.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Weight loss is desired by many patients, but many primary care practices struggle to provide this care. Setting or Data Set: Semi-structured interviews conducted with clinicians and staff between February 2021 and October 2023 (N=220). Outcome Measures: Key themes and adoption groupings.

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Annals of Family Medicine

NOVEMBER 20, 2024

to complete an analysis of qualitative data collected from primary care clinician and staff perspectives on the use of anti-obesity medications. Setting or Data Set: Baseline and follow-up semi-structured interviews conducted with clinicians and staff between February 2021 and August 2023 (N=220).

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Physician's Weekly

JUNE 25, 2025

It’s “going to streamline it in some incremental ways only,” Dr. Adam Gaffney , a critical care doctor and assistant professor at Harvard Medical School, told NBC News. Insurers must provide clearer explanations when care is denied and explain how patients can appeal.

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Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. But these early systems often struggled with complex medical terminology and the natural flow of conversation.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Michelle Ogunwole, MD, PhD, an internist and social epidemiologist who specializes in the care of women with chronic medical conditions and racial disparities in maternal health outcomes, and Dr. Caroline Sloan, MD, a general internist whose research focuses on how financial considerations are imbued into medical decision-making.

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FDA Law Blog

OCTOBER 5, 2022

eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. add-to-files). add-to-files). eSTAR submissions are automated (e.g., form construction, auto filling).

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Physician's Weekly

JUNE 24, 2025

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. “I’m sort of hectoring,” she acknowledged. The evidence that vaccines are beneficial remains overwhelming.

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FDA Law Blog

AUGUST 9, 2023

However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. 48365, 48369 (July 27, 2023).

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FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). By Larry K. Zarzamora Press Release.

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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 ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2023 Apr;21(2):166-7.

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FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

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FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. The final rule will be effective February 21, 2023. Thus, these regulations apply to a huge variety of products.

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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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FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ).

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FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023.

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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

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. There are additionally places to provide attachments for test reports and other supporting documents. By Adrienne R. New Labeling Requirements.

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GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective: 1) Demonstrate the feasibility of collecting data from prescription drug monitoring programs (PDMPs) for population health reporting, 2) analyze trends in PDMP and electronic health record patient data relative to CDC guidelines and 3) identify use of patient-centered measures for pain management in primary care.

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Medical Xpress

JUNE 16, 2025

DOI: 10.1038/s41467-025-58661-1 Journal information: Nature Communications Provided by National Taiwan University Citation : Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright.

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FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter. October 1 – December 31. January 31.

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The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. ’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals.

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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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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Updated 2023 Jul 17]. Pediatr Rev.

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GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.”

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GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. And it’s not the same, but it does provide information. Bill, welcome to the GeriPal podcast. Bill 00:53 Thank you, Alex.

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FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. 29, 2023) (“Basis”); NPRM at 44,603. 21 U.S.C. § 21 U.S.C. § 44,597 (May 21, 2024).

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FDA Law Blog

JUNE 10, 2025

The agency revised the list in October 2023 when it added twenty-eight chemicals, removed two List I chemicals automatically included as a laboratory supply and added “tableting machines, including punches and dies.” One commenter, without providing details, asserted that the chemical may have uses in the medical field.

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