FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

DECEMBER 2, 2022

Rather they’re Ill, maybe they’re aging unsuccessfully, but never really resilient. How do you maintain successful aging, which is often free of disease or illness or disability? We need to learn from them that they have moved on, so how do we not dwell in the past negative events? It is progressive.

Community 101

Community IT Individual Patient-Centered 101

GeriPal

OCTOBER 13, 2022

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). difficile infections.

Complication 97

Complication Patient-Centered IT Patients 97

GeriPal

MAY 19, 2022

It depends on the clinical situation. And really, the best that had ever been looked at, especially in our population and sort of a cancer serious illness population. But I think people would have an embolic event if you gave them a flipping range. Eric: All right. We want to switch from, let’s say morphine to Dilaudid.

IT 139

IT Patients Individual Relationship 139

Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. Primary prevention intervenes before injury (seatbelts).

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Medical Student Diagnosis Physicals Medical 246

PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. uh, ill defined epigastric or chest pain, and it’s often worse by eating or lying down after meals. Thank you for listening to this episode.

Diagnosis 52

Diagnosis Management Patient-Centered IT 52

Physician's Weekly

JUNE 26, 2025

Consecutive, critically ill adults with a Glasgow Coma Scale score of 3, who were at high risk of DNC, were included. The primary analysis included 282 patients; 72 percent were ultimately declared deceased by standardized clinical criteria. Michaël Chassé, M.D., The sensitivity of CT angiography ranged from 75.5

Illness 52

Illness Patients Clinic 52

GeriPal

OCTOBER 5, 2023

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. We need to strike it from our vocabulary and leave sort of a gap in the clinical vernacular about how we talk about life-sustaining treatment. Eric: Why is it?

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

JUNE 13, 2024

Summary Transcript Summary I always find cachexia in serious illness puzzling. In today’s podcast, we had the opportunity to learn from a renowned expert in palliative care, Eduardo Bruera, about cachexia and anorexia in serious illness. When people have no appetite, they know they’re ill. Eduardo 10:42 Sure, Eric.

Illness 133

Illness Patient-Centered Patients IT 133

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Two of our guests today, Stacy Fischer and Brian Anderson, are involved in large multicenter trials of psychedelics for patients with advanced cancer (Fischer) or life-limiting illness (Anderson).

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Patient-Centered Community IT Medical 91

My Green Doctor

MAY 29, 2025

In the United States, extreme weather events and air pollution are already costing the healthcare system over $820 billion annually. This means: Direct influence: Training healthcare professionals to understand and manage the growing connections between environment and illness. But this is not only a European story.

Healthcare Professional 52

Healthcare Professional Healthcare Finance Education 52

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. So there’s an event or a series of events.

Patient-Centered 66

Patient-Centered IT Screening Patients 66

GeriPal

JULY 28, 2022

GeriPal post on “fast food” style palliative care in chronic critical illness. Areej: So when I was in college, I had a close friend who had a serious illness and actually died as a result of cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. Ann Henshaw is an occupational therapist who works clinically at Georgetown and teaches at GW. Alex: Today we are delighted to welcome Ann Henshaw who brought this podcast idea to us.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

JULY 11, 2024

Can you come and be in our clinic once a week? It used to also be a social worker and myself who would actually go to clinic and spend some time up there. And so I was driven by the fact that I needed more information, and so it sort of became my clinical focus as well as I dabble in the research.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

GeriPal

MAY 25, 2023

LJ: I’ll take that one that I feel really strongly that we are not assessing the right outcomes in advance care planning, and I think that’s part of the problem, is that we I think we do this in a lot of science and a lot of research in clinical medicine too. Hillary: So those all differ. Alex: LJ, are you going to add to that?

Community 95

Community IT Patient-Centered Primary Care 95

GeriPal

NOVEMBER 7, 2024

We also briefly mention Susan Wong’s terrific studies that found a disconnect between older adults with renal failure’s expressed values, focused on comfort, and their advance care planning and end-of-life care received, which focused on life extension; and another study that found quality of life was sustained until late in the illness course.

Management 116

Management Patient-Centered Patients IT 116

GeriPal

FEBRUARY 17, 2022

This tool provides a clinical recommendation for starting/stopping medications and cancer screening based on the prognosis of the patient in front of you. And they really have been shown in several clinical trials to have reductions in vertebral fractures, non-vertebral fractures, and hip fractures. See screenshot below.

Clinic 67

Clinic IT Patients Medical 67

GeriPal

OCTOBER 20, 2022

There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. And I think that’s where this clinical trial which looked at seven versus 14 days was really practice-changing for many of us. difficile infections. difficile that patients are exposed to and antibiotic resistance.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JUNE 30, 2022

So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. We think there are some cases, certain kinds of illnesses or conditions or operations, where people have the surgery and never get out of bed again.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. Participants were critically ill and intubated. P AI R stands for Palliative and Advanced Illness Research Center. What is sludge?

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

FDA Law Blog

JUNE 4, 2025

This Assessment does not itself prescribe specific remedies for the ills it diagnoses; those are supposedly coming in the future Strategy document. Known clinically relevant safety and effectiveness information is generally included in the label under current practices.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty. Lauren: Yeah.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

OCTOBER 12, 2023

Gretchen: Yeah, I think probably the underlying story here is that I’m really good at doing negative randomized clinical trials, but there is a good thing about doing a big clinical trial, which is that you get tons of data even if you don’t end up with the result that you want. And that’s how we connected.

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IT Families Family Patient-Centered 128

GeriPal

OCTOBER 27, 2022

As Alex Lee says on our podcast today, all prognostic models will be wrong (in some circumstances and for some patients); our job is to make prognostic models that are clinically useful. As Sei Lee notes, the argument for developing prognostic models has won the day, and we increasingly use prognostic scores in clinical decision making.

IT 95

IT Clinic Screening Patients 95

GeriPal

DECEMBER 5, 2024

It’s that mixture of intimacy and vulnerability, of shared clinical experiences, that fosters a sense of belonging. We definitely draw on the sciences, on biomedical science, on clinical trials, on pharmaceutical design and all sorts of things like that. There’s something magical that happens in small group storytelling.

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IT Community Patients Families 107

GeriPal

MARCH 13, 2025

Alex Smith Links Link to the McGill National Grand Rounds Series on Palliative Care , Michael Kearney as initial presenter, and registration for future events. When we first started, they were concerned about the fact that nurses were going to be only working with people that were very ill and people that were grieving. by Kearney.

IT 104

IT Patient-Centered Families Family 104

GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Tsai-Chin 01:02 Thank you.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

SEPTEMBER 12, 2024

So whether it’s an encounter with a patient or whether it’s a family meeting or a clinical practice meeting or a feedback session with a fellow, the idea that we have both the ability to be very full and open and also selective and disciplined about how it is that we. I backed into that role. That’s true.

IT 110

IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

FEBRUARY 8, 2024

The illness narratives suffering, healing, and the human condition. 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.

IT 137

IT Families Family Physicals 137

GeriPal

MAY 22, 2025

Jenny Chen is a palliative care fellow at Yale who regularly sings for her seriously ill patients. Theresa 28:12 In 20 years, I have once seen somebody deliberately choose a song that was so traumatic, I had to actually put in my very first adverse event report. Eric 28:10 Eric, it’s been 20 years. But back to the point.

IT 96

IT Patient-Centered Patients Board-Certified 96

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. But now we have older people dying of older people illnesses. There are clinics. He struggled with mental illness, substance use disorder. Michele: Yep.

Families 132

Families Family IT Community 132

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. They had triple diagnoses, often life threatening illness, but also mental illness and usually some kind of addiction.

IT 122

IT Patient-Centered Patients Relationship 122

GeriPal

FEBRUARY 2, 2024

And PAIR stands for the Palliative and Advanced Illness Research Center. So, Alex, imagine you’re a seriously-ill hospitalized patient and I’m your doctor, unluckily for you. But you could have clustering within clinics, within clinicians who care for a panel of patients, that sort of thing.

Consulting 120

Consulting Hospital Patient-Centered IT 120

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. Jennifer 07:31 From.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

MARCH 16, 2023

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. In clinic, I’m helping what, hundreds or thousands. Louise: Well again, if you take that approach, you also get rid of ableism and ageism against children and prejudice against people who are ill.

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IT Healthcare Professional Healthcare Transportation 105

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. So the palliative performance scale, or PPS, is essentially a tool to help clinicians with prognostication for seriously ill or palliative care populations.

Families 106

Families Family Patient-Centered Patients 106