FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Barton Associates

MAY 8, 2025

Reducing Burnout Among Permanent Staff Did you know that nearly half of physicians (45.2%) reported at least one symptom of burnout in 2023? The varied backgrounds of temp medical staff, like locum tenens providers, allows these professionals to: Introduce best practices and innovative clinical approaches from other healthcare settings.

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

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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. The Court held that it does.

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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. But many people are not receiving adequate care—in fact, 23% of all U.S.

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PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. These articles will take another look at the content included in this episode.

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Physicians Alliance of Connecticut

MAY 27, 2025

Opportunities for healthcare admin assistants across Connecticut are growing, from clinics and hospitals to private practices like the Physicians Alliance of Connecticut. Bureau of Labor Statistics projects that employment for medical secretaries and administrative assistants will grow by 5% between 2023 and 2033.

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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. Each of these De Novos can represent a clinical advance. De Novos now play an important role in product advancement.

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The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

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Logansport Memorial Hospital

MARCH 7, 2024

For many, being in a clinical setting can spike stress and anxiety. But 2023 was a really bad year for me between the infection and everything. When it comes to wound care, stress can play a major factor in your healing journey. I went through 7-8 rounds of antibiotics because I kept getting small infections, and I had cellulitis.

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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., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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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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PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Pediatrics March 2023; 151 (3): e2022057383. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. Coker, Gretchen J. Cutler, Matthew Hall, Rustin B.

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The Clinical Problem Solvers

NOVEMBER 3, 2022

He has a passion for both clinical and academic neurology and will be starting neurology residency in the summer of 2023. He has special interests in neurophysiology, autoimmune neurology, and neuroimmunology, but is excited about all neurological fields.

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FDA Law Blog

MAY 8, 2023

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Updated 2023 Jul 10]. Pediatrics. doi: 10.1542/peds.2018-0333I.

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FDA Law Blog

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. as a de novo special control or in a guidance document for a specific device type). Comments on the draft guidance are due on or about March 8, 2023. In one way, this is good news.

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FDA Law Blog

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. How to leverage “programs such as the New York State Department of Health Clinical Laboratory Evaluation Program (NYSDOH CLEP) or those within the Veterans Health Administration (VHA).”

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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. This is what Greg was talking about, life coaching blurs with executive coaching.

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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.

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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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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. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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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. But what happens inside the SCN after receiving this light signal has remained largely mysterious—until now.

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ABIM

MAY 30, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to inform operations, such as updating exam blueprints, developing policies for initial certification and MOC, and ensuring adequately diverse representation of the profession in research and governance.

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PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Clin Toxicol (Phila) 2023; 61:453. Further complicating matters is that each inhalant has its own special risks. Intelligencer.

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. So my special guest host on this episode is a trainee in pediatrics and medical genetics. On clinical presentation. Inborn Errors of Metabolism.

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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. James 00:32 Good afternoon.

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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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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. It was statistically significant, but not all of it was clinically meaningful.

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GeriPal

APRIL 6, 2023

Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. Okay, I don’t necessarily want to stay clinical, but I really love that spiritual work and what’s the closest profession. And we don’t know very much about how all of those overlap.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. She softened to her suffering, and she trusted me enough to have a moment, that she could look into that and see that, yes, she had her clinical judgment, which was fine, but also that there was another processes going on, which was her own suffering. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004.

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GeriPal

AUGUST 15, 2024

Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. We do a lot of clinical focused discussions. We shouldn’t be screening every older age and adult who comes into our clinic about these incidents for different reasons. As far as the numbers, pretty significantly.

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GeriPal

JULY 13, 2023

Randy died February 26, 2023. It’s really special to be here and to be talking about this paper, which was really important to Randy. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. Randy Curtis was first author of the JAMA paper.

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GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. Alex: But the longer title’s Ethno-Geriatrics and Special Populations. The journal section’s requirements are the same as for a clinical investigation. ” It was in my slide deck.

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GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. ” Diane: Fantastic. Think about CPC+.

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GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. And by the way, we have really good reason for that because this isn’t like a prescribing clinician within a clinic or an outpatient clinic or something. Start with a story as Carly did in her Op Ed.

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