FDA Law Blog

MAY 17, 2022

It’s the quinquennial event when many of the UFAs are up for reauthorization. Under the interpretation in the Catalyst decision, such an approval would result in exclusivity for their drug for the entire disease, even though the sponsors did not invest in studying and developing their drug for all individuals with the disease.

IT 40

IT Patients Provider Individual 40

PEMBlog

OCTOBER 2, 2024

Red flags that you should always ask about include hematemesis, melana, dysphagia, and Unintentional weight loss, these all need further investigation for complications like esophagitis or another diagnosis such as EOE or peptic ulcer disease. This measures both acid and non acid reflux events. It kind of blunts them down.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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Referral 40

Referral DO Family Medicine Primary Care 40

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 115

Community Transportation IT PCP 115

GeriPal

OCTOBER 20, 2022

And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. difficile infections. So you’re right.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JUNE 30, 2022

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. You have a patient with dementia severe enough that she cannot recognize relatives.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

MAY 25, 2023

Complicated grief? And I’ll just say that I think what we know is there’s been so much greater advance care planning research and and at many levels, at a at an individual level, at a health system level, at a policy level. And then individuals will still have questions of really, how can I help my wishes to be known?

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

JULY 11, 2024

I’ve seen patients post transplant when they start having complications. They are complicated. They’re complicated from a symptom standpoint. And so I honestly think it has to do with how complex the diseases and the complications that come from it. Can you come and be in our clinic once a week?

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

GeriPal

MARCH 9, 2023

Psilocybin, the most commonly used psychedelic, increases heart rate and blood pressure, which may potentially lead to cardiovascular events. Alex: It’s complicated. We, for very complicated reasons, ended up with niacin. Most participants are White and well-resourced. So, creating a- Alex: Control condition. Eric: Yeah.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

MAY 29, 2025

Andrew complicates this definition , stating it raises more questions than answers. 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? Andrew could talk about. And the Clin.

Family 93

Family Families IT Patient-Centered 93

GeriPal

JANUARY 26, 2023

Second, as we discussed in last week’s podcast , older adults, particularly those in nursing homes, were far more likely to die than younger individuals. We lump everybody who’s 65 and older together, and then we don’t look at the individual characteristics of that person, so we fall into these patterns based on racial premises.

IT 92

IT Patient-Centered Healthcare Patients 92

GeriPal

NOVEMBER 7, 2024

Or is it just this lingering practice of starting dialysis early before really severe complications develop? So we created these heat maps where you could see for each individual what actually happened in the days and you. And that biases them because they’re immortal in a sense, until that event happens. Maria 36:03 Yes.

Management 116

Management Patient-Centered Patients IT 116

GeriPal

MAY 15, 2025

The events are conditions that’ll be set into place unless some active choice to the contrary is chosen. We did another nudging trial where the deep default was for default palliative care consultations for high risk patients, and it significantly increased individuals who were receiving palliative care. I highly encourage you.

Patient-Centered 117

Patient-Centered Hospital IT Illness 117

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. I think it’s really, really complicated. Lauren: Really?

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. And this is really traumatic event for his street family and the street community that he knew. We talk a lot about people being unhoused, which I think takes the blame away from the individual and kind of de.

Healthcare 100

Healthcare IT Community Illness 100

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”? Usually events open up some insight into the person themselves as they’re describing the suffering.

IT 137

IT Family Families Physicals 137

GeriPal

OCTOBER 26, 2023

I know that from Sarguni, we have some population level data, but are there any individual tools that you could use like an e-prognosis for function for hospitalized older adults? Tamra: It’s incredibly complicated because to date, there’s not really a validated tool that’s mandated to be used across all settings.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

JULY 28, 2022

Jennifer: I think it’s such a complicated question. So I think until we figure out how to deliver these evidence based interventions in resource intense places with individuals like you, who are committed to research, committed to furthering the science, it’s really hard to think about how to disseminate them to the community.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

JULY 25, 2024

This is a particularly interesting topic because we know that individuals with dementia have a high rate of entering nursing home. That just leads to issues that can make home care very difficult for these individuals. So you’re kind of the guest host today. Why did you do that paper, James? James 17:03 Yeah, I think so.

Family 106

Family Families Patient-Centered Patients 106

GeriPal

JULY 16, 2024

I think what ageism, when you get right down to it, is, is not really seeing the individual in front of you and the individual in the setting of what they’re trying to accomplish and what matters to them, that it’s always appropriate. Eric 04:17 How do you think about that? There is a tension. So can I ask a question?

Diagnosis 141

Diagnosis IT Diagnose Physicals 141