FDA Law

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

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.

IT 66

IT Patient-Centered Screening Patients 66

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Psilocybin, the most commonly used psychedelic, increases heart rate and blood pressure, which may potentially lead to cardiovascular events. Most participants are White and well-resourced.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

FEBRUARY 17, 2022

When we have a medication with up front harms and downstream benefits, it’s critical that we consider the time to benefit, or how long it will take an individual to benefit from a test or treatment. Think of the 10 years it takes to benefit from colon or breast cancer screening, which is designed to detect slow growing cancers.

Clinic 67

Clinic IT Patients Medical 67

GeriPal

FEBRUARY 15, 2024

And so to them, the real frustrating part is they’re supposed to be treating people like it’s a one-time event the very first time, and the system of EMS is not designed to be longitudinal complex care, and yet that’s basically what we’re seeing happening. All of these are factors that are on the individual level.

Community 114

Community Transportation IT PCP 114

FDA Law

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. So this is something. We did a role play.

IT 64

IT Hospital Screening Patients 64

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

MAY 29, 2025

I think we have ideas about are these paradoxical events, are they expected? And I think Andrew’s going to have good ideas about, like, why the term paradoxical and are these events paradoxical, truly? And I think this just hasn’t made it into, like, our academic clinical training space. Andrew could talk about.

Family 93

Family Families IT Patient-Centered 93

GeriPal

FEBRUARY 8, 2024

So there’s this, what is suffering to the individual, and is there some threshold that we could say, “This is real suffering,” or “This is the suffering we talk about in geriatrics or palliative care”? .” ” That’s not a spiritual screen. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004.

IT 137

IT Family Families Physicals 137

GeriPal

JULY 28, 2022

I had it on my screen. And so often, these patients experience a lot of hospitalizations, numerous hospitalizations while they receive intensive chemotherapy that requires prolonged periods of neutropenia and toxicities, or stem cell transplantation, which is what I specialize in clinically now. What was the title of it, again?

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited.

Healthcare 129

Healthcare IT Education Hospital 129

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. ” It was in my slide deck.

Mental Health 123

Mental Health IT Community Individual 123

GeriPal

DECEMBER 1, 2023

Summary Transcript Summary There is a growing push to change how we define Alzheimer’s disease from what was historically a clinically defined syndrome to a newer biological definition based on the presence of positive amyloid biomarkers. So too systolic hypertension in elderly people, clinical trials. Alex: That’s right.

IT 115

IT Clinic Illness Hypertension 115

GeriPal

AUGUST 1, 2024

So if you already have a condition, you might be able to prevent events. And for any, any diet, it can, we can really tweak it to an individual’s preferences, their needs, that kind of thing. Eric 18:14 Elizabeth, how do you bring it up in your clinic? So fourth year is where you start your clinicals.

IT 116

IT Diabetes Chronic Disease Patient-Centered 116

GeriPal

JULY 16, 2024

We talk about positive aspects of aging, cognitive screening, the line between legitimate concerns and ageism, ableism, advice for a geriatrician asked to comment on TV, frailty and physical disability, images in the press , historical situations including , and an upper age limit for the Presidency, among other issues.

Diagnosis 141

Diagnosis Diagnose IT Physicals 141