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. It also covered related pain management and physical therapy after she returned home to New York City. The bills totaled more than $100,000. There goes my retirement.’”

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Physicians Alliance of Connecticut

APRIL 12, 2025

Bureau of Labor Statistics projects that the field will grow by 15 percent from 2023 to 2033 , which is higher than the average for roles that provide support to healthcare professionals. The need for medical assistants is growing rapidly. We’re always looking for talented and hardworking people to join our team.

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FDA Law Blog

MAY 19, 2023

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. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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Logansport Memorial Hospital

MARCH 7, 2024

But 2023 was a really bad year for me between the infection and everything. Healing chronic wounds at Logansport Memorial’s Wound Care Center The Logansport Memorial Wound Care Center provides specialized treatment, including hyperbaric oxygen therapy, for chronic or non-healing wounds, right here at home. But then I got the flu.

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Patients Patient-Centered Diabetes IT 52

PEMBlog

JUNE 7, 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 what prehospital providers should do to get these agitated children safely to the ED.

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Transportation Patient-Centered Management Finance 123

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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Aspiring Minority Doctor

FEBRUARY 7, 2023

I’m actually about to land soon and can barely keep my eyes open as I’ve been traveling since yesterday, but I wanted to get this started so that I can finish and hopefully post tomorrow. I figured I didn’t have a chance in hell at winning, but I shared anyway because 1) I’m always happy to share my story with hopes that it uplifts/inspires others.

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FDA Law Blog

AUGUST 18, 2024

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. The classification order identifies the special controls and therefore is extremely important.

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Plum Health

AUGUST 20, 2023

It also discusses cultural events, the best coffee shops to study, the best parks to relax and unwind, and the best restaurants for a student budget and for when parents or loved ones come to town for a special occasion.

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PEMBlog

MAY 31, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. 2023 Mar 21:S1876-2859(23)00091-8. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate pharmacologic management strategies for agitated children.

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Management Patient-Centered Transportation Finance 91

PEMBlog

MAY 17, 2023

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

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FDA Law Blog

OCTOBER 12, 2023

Such an ANDA therefore can be submitted only upon the submission and approval of a special Citizen Petition, called a Suitability Petition. Like with other types of Reviews, FDA will assign a “goal date” to any Suitability Petition submitted after October 2, 2023. Under 21 C.F.R. covering ANDA Suitability Petitions.

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FDA Law Blog

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. 21 U.S.C. § 802(54)(D)(i). 21 U.S.C. § 802(54)(D)(i).

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Aspiring Minority Doctor

DECEMBER 30, 2022

I'm just seriously so blessed to have such an amazing daughter and I'm even more so grateful that I was able to spend her special day with her and celebrate in a way that she wanted. I am excited for 2023 and for the wild ride I'm sure it will take me on. Yep, the little one turned 16 in November! Can you believe it?!?!

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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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PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Pediatrics March 2023; 151 (3): e2022057383. It is also the final episode in a 5 episode series focused on agitation in children and adolescents. These articles will take another look at the content included in this episode.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Fields Time Stamps 00:00 Mission, vision, and introductions of hosts 01:30 Background on three-episode series 02:26 Introductions of guests 04:16 How Dr. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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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

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

FEBRUARY 22, 2023

as a de novo special control or in a guidance document for a specific device type). By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.

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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. …and it’s called Hemlibra (Emicizumab) Why this med is important and why kids are on it?

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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. eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. ECPR involves using ECMO (Extracorporeal Membrane Oxygenation) to take over heart and lung functions, offering a last-resort option that is becoming more common in large pediatric hospitals. Am Heart J.

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FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are two forms: one for non-IVD devices and one for IVD devices. There are two forms: one for non-IVD devices and one for IVD devices.

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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. SAMHSA operates the 988 Lifeline, a suicide and crisis hotline that has received nearly 14.5 Our patients’ lives depend on it.

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Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. DEA’s notice of updates with the Special Surveillance List is attached here. By Larry K.

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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. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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FDA Law Blog

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 39,479, (June 16, 2023).

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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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The Motivated MD

SEPTEMBER 19, 2024

Saving $23,000 when the national average unweighted resident salary in 2023, according to AAMC data , was $63,800. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes. This is the same for personal finances. Fight this temptation.

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FDA Law Blog

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. Final Guidance at 2.

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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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