Physician's Weekly

JUNE 19, 2025

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. If people in these groups don’t sign up for Medicare when they become eligible, they can find themselves responsible for all their medical bills for years.

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PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

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PEMBlog

MAY 31, 2023

However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option.

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability).

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Plum Health

AUGUST 20, 2023

These medical students will be immersed in the Detroit community over the next 4 years, and upon graduation, many of them will continue to serve the Detroit and Metro Detroit community. WSU SOM’s incoming class of 2026 had 300 Students, with 192 in-state and 108 out-of-state students.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. These legislative changes helped.

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FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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PEMBlog

MAY 17, 2023

Why then do we persist with the “is it medical/organic or psych” question? Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. It is also episode 1 in a 5 episode series focused on agitation in children and adolescents. Government.

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FDA Law Blog

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Aspiring Minority Doctor

FEBRUARY 7, 2023

My original flight was changed by the airline a couple of months prior, so I specifically added the Atlanta layover so that I could have lunch with one of my dearest friends from medical school, but she absolutely surprised me with the best birthday gift ever! For those who don’t know, this is one of my favorite designers.

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PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

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FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § That emergency declaration is set to expire on May 11, 2023.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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FDA Law Blog

NOVEMBER 5, 2023

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. Philip Won , of Hyman, Phelps & McNamara, P.C. The comprehensive agenda for the symposium can be accessed in its entirety here.

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). See 21 CFR 807.81(a)(3)

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Patients on emicizumab will have it listed on their medication list. How to know if a patient is on it?

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GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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FDA Law Blog

OCTOBER 6, 2023

The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

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FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

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PEMBlog

AUGUST 20, 2024

2023; 187:109792. So, eCPR, extracorporeal cardiopulmonary resuscitation, is an advanced medical procedure used in cases of cardiac arrest where traditional CPR has failed. eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. Am Heart J. 2020;229:29–39. Resuscitation.

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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. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). Learnings on how eSTAR works Starting Too Early.

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Doctors for America

MAY 15, 2025

Nearly 50,000 people died by suicide in 2023 and another 12.8 Contact your senators and state representatives in support of SAMHSA. ### About Doctors for America: Doctors for America mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation.

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Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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Medical Xpress

JUNE 16, 2025

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). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. When Bob changed jobs, the price tag for his daughter’s medication went through the roof. He’d have to pay more than 500 dollars. He left without it.

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Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone.

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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. So yes, humans make mistakes.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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Physician's Weekly

JUNE 23, 2025

MONDAY, June 23, 2025 (HealthDay News) — The National Institutes of Health (NIH) will fund studies of the long-term health effects of a 2023 Ohio train derailment that released more than 1 million pounds of hazardous chemicals into the soil, air and water. We desperately need real medical support.”

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FDA Law Blog

JULY 29, 2024

Newberger — In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. By Jennifer D.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A. The illness narratives suffering, healing, and the human condition. Naomi: Yes, I do. Everybody Hurts by REM. Alex: Yeah.

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children.

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FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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PEMBlog

JANUARY 16, 2025

Clin Toxicol (Phila) 2023; 61:453. As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint. Updated February 26, 2024.

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