PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

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FDA Law Blog

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. And, like it has before , the District Court of D.C. recently grappled with this very question in Ipsen v.

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IT Specialization Patients 95

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). The opioid epidemic has led DEA to take a more aggressive approach to cyclic and on-site inspections.

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Management Manufacturing Specialization IT 52

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. DEA regulations require “adequate security” but do not specially require cameras in health care facilities.

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Board-Certified Provider Government Management 52

FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). mobile applications to capture patient-reported outcomes through questionnaires). DHTs include monitoring instruments (e.g.,

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). The opioid epidemic has led DEA to take a more aggressive approach to cyclic and on-site inspections.

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Management Manufacturing Specialization IT 40

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

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Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. I was coaching someone this morning, who really wanted to know, what does your clinic template look like, and how do you respond to patient messages?

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Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

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Vascular Physician

DECEMBER 2, 2020

The TCAR procedure also utilizes a special tool that reverses the blood flow that usually goes from the aorta to carotid and to the brain. Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With Carotid Artery Stenosis. Accessed March 10, 2020.

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Utilities Complication Specialization Hospital 52

Medical Xpress

JUNE 16, 2025

Explore further Trials using psychedelic drug to treat trauma, addiction endorsed by Texas Legislature shares Facebook Twitter Email Feedback to editors Featured Last Comments Popular Decades after 9/11, PTSD remains a persistent burden for thousands of responders 3 hours ago 0 A single enzymatic switch steers cell fate in intestinal regeneration Jun (..)

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Mental Health IT Medical Specialization 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This segues into a conversation about the legacy of the war on drugs and today’s racial inequities in opioid addiction treatment.

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Community Patient-Centered Mental Health Board-Certified 52

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) or Canada to become eligible for ABIM Board Certification.

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Diabetes Board-Certified Telehealth Government 52

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life.

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Patient-Centered IT Illness Patients 122

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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Provider Medical Complication Diabetes 109

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. In June, ABIM issued notice about an opening on the Infectious Disease Board for a public member with patient or caregiver experience in infectious disease for a term beginning July 1, 2025.

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Georgetown Pediatrics & Family Medicine

FEBRUARY 10, 2023

In addition to a special day called Valentines, I would like to bring awareness to why we should keep our hearts healthy. According to the CDC, “About 697,000 people in the United States died from heart disease in 2020– that’s 1 in every 5 deaths”. Sleep Better: Many patients state that they experience trouble sleeping.

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Primary Care Physician Family Medicine DO Appointment 40

ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. At the time of the spring 2025 meeting, ACGME had reviewed the proposal, which outlines clear roles for program directors and emphasizes both patient care and transplant knowledge.

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GeriPal

FEBRUARY 8, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. 2023.11.004.

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GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. But my piece in the New England Journal is about being a patient right before awake brain surgery. I could learn this.

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IT Patient-Centered Patients Healthcare 95

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Patient-Centered IT Hospital Patients 77

GeriPal

DECEMBER 5, 2024

We talked with Thor Ringler, who helped found the My Life My Story Project at the VA and beyond, and Heather Coats about the evidence base for capturing patient stories. So has a special resonance for, I think, a lot of people who are Tragically H ip fans. Because we all interface with it at the end of the day as patients.

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IT Community Patients Families 107

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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Supply Chain Manufacturing Government Hospital 59

GeriPal

FEBRUARY 20, 2025

If you want a deeper dive, check out the following resources: Our Nature of Suffering podcast with BJ Miller and Naomi Saks Dani Chammas Annals paper on countertransference and why we shouldnt say that the patient was difficult rather than that I felt frustrated. Eric 04:55 Does it need an experience directly? I guess that’s an event.

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IT Patient-Centered Individual Screening 66

GeriPal

DECEMBER 7, 2023

Big heat waves in England in 2020, 2,224 excess deaths in the obits over the age of 65. I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So how are your patients going to deal with extreme heat and cold? They can save a lot of money.

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FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider.

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IT Provider Government Patients 52

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. Isn’t that what we always work with, with patients, with our colleagues, with ourselves? Can I ask, Redwing, do you ever ask patients or people you care for to write poetry? Alex: Mm-hmm (affirmative).

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Patient-Centered IT Community Illness 93

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Everything.

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GeriPal

JULY 14, 2022

Two-thirds of the patients in the home now have COVID-19. Seventeen of your patients are dead. The other physicians who previously saw patients in the nursing home are no longer coming to your facility because you have COVID positive patients. You’re short on gowns and facemasks. Eric: Welcome to the GeriPal Podcast.

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Nurse Practitioner Patient-Centered Vaccination Emergency Room 136

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. 2020 Hospital at Home-Plus: A Platform of Facility-Based Care. But we ended up doing, basically, a case series of… I think it was 18 or 20 patients or so.

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Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have.

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