FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e., Software in a Medical Device, or SiMD).

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Physicians Alliance of Connecticut

MAY 27, 2025

Healthcare administrative assistants manage crucial administrative tasks in medical offices. As a healthcare administrative assistant, your day-to-day tasks may vary depending on the needs of the medical office. Healthcare administrative assistants, from private practices to hospitals, are vital in medical facilities.

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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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Transportation Patient-Centered Management Finance 123

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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Medical Xpress

JANUARY 3, 2025

billion in 2023, is rapidly growing. UC Davis Health molecular exercise physiologist Keith Baar specializes in sports medicine and studies the effects of collagen, whey and omega-3 supplements on bone and tendon health. The global dietary supplements market, valued at $178.8

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Specialization 85

Barton Associates

MAY 1, 2025

adults had a mental illness in 2023, and about half (46%) of them did not get any treatment. Nurse practitioners are actually the third-fastest growing occupation in the United States, with a projected 46% growth rate between 2023 and 2033, according to the BLS. Can a mental health nurse practitioner prescribe medication?

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Medical Xpress

APRIL 4, 2023

New research in the April 2023 issue of the Journal of the National Comprehensive Cancer Network finds that specially trained oncology infusion room nurses can improve advance care planning (ACP) for patients with advanced cancer. In this study, oncology nurses underwent an immersive, three-day training session on palliative care.

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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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Management Patient-Centered Finance Transportation 91

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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Medical Xpress

APRIL 24, 2023

A pilot study conducted at Hospital for Special Surgery (HSS) shows evidence that a mid-calf nerve block is a safe and effective regional anesthetic option for foot and ankle surgeries and may enable faster recovery of motor function of the ankle joint compared with a popliteal block.

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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.

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Medical Xpress

APRIL 24, 2023

In a study conducted at Hospital for Special Surgery (HSS), researchers found that the use of peripheral nerve blocks in total knee and total hip arthroplasty were associated with a consistent reduction in risk for postoperative complications in patients with a lower comorbidity burden.

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Patients Complication Specialization Hospital 72

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. Furthermore, the connection between physical and functional symptoms is inextricably linked in many patients. Government.

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Patient-Centered Mental Health Management Finance 71

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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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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Mental Health Management Patient-Centered Illness 98

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! It made me feel so special and loved.

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IT Medical Mental Health Patients 52

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

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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The Clinical Problem Solvers

NOVEMBER 3, 2022

Neurology DDx Schema John Acquaviva @DrJAStrange John Acquaviva is a fourth-year medical student attending Lake Erie College of Osteopathic Medicine in Erie, Pennsylvania. He has a passion for both clinical and academic neurology and will be starting neurology residency in the summer of 2023. She was born and lives in Lima, Perú.

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Medical Student Internal Medicine Insurance Specialization 52

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. Black Ball Freight Serv. , 532, 539 (1970) (cleaned up).

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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. It’s Time to Talk about Racism in Medical Education. Links References discussed throughout episode Tsai J. link] Tsai J.

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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.

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Engineering Specialization Community Medical 52

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Industry stakeholders seeking to provide feedback to FDA can submit comments to Docket: FDA-2022-D-2628 by July 3, 2023.

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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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Manufacturing Engineering Medical IT 64

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

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. Epub 2023 Jan 16. Epub 2021 Oct 10.

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Individual Patient-Centered Patients IT 52

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. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

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Provider Manufacturing IT Medical 64

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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Patient-Centered Hospital Patients IT 52

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).

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Provider Electronics IT Complication 52

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

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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). AlexSmithMD 1. It’s also a lot what stage of career they are. Beth: Yeah. Greg: Yeah. .”

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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 information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

Mental Health 52

Mental Health IT Medical Specialization 52

Doctors for America

MAY 15, 2025

Nearly 50,000 people died by suicide in 2023 and another 12.8 DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization. DFA teaches physicians and medical students advocacy skills and does advocacy at a state and federal level.

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Mental Health Medical Student Community Provider 52

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. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. What are the consequences?

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Provider Medical Complication Diabetes 109

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. They started trying out different medications and dosages.

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