FDA Law Blog

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Livornese and Josephine M. If FDA accepts the application, the sponsor can then submit their supplement in two parts.

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Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

FEBRUARY 15, 2024

Panelists Carmen Quatman and Katie Quatman-Yates have no relationships to disclose. And so someone knocked on my door when I was in fellowship and said, it was the EMS coordinator, the emergency medical service coordinator next door, our educator, and said, “Hey, we have this really weird problem. Eric: Oh, that’s fabulous.

Community 116

Community Transportation IT PCP 116

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. Weren’t those the days?

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Family IT Families Diagnosis 102

GeriPal

MAY 12, 2022

Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. Raj: That’s one of the high tech medical absurdities that we have developed.

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Community IT Relationship Healthcare 116

GeriPal

AUGUST 17, 2023

So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them? And I do think geriatricians need to as individuals make that decision, largely based on their comfort with the diagnostics and the specifics of the therapeutics. I’m a prescriber.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

APRIL 24, 2025

And so this term was developed by our group to capture either non traditional therapies or really conventional medical therapies that patients may be pursuing with little hope of reaching a goal of care and significant risk. Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. Did I say that correctly?

Patient-Centered 79

Patient-Centered IT Patients Illness 79

GeriPal

OCTOBER 3, 2024

I was on a retreat with Guy Micco , who’s been on this podcast several times, and he was teaching a class on death while I was in medical school. What is it about the images of the dying that helps teach medical students? And dying is too big, too profound for any one model, including the medical model. Wendy, I have.

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IT Patient-Centered Patients Relationship 123

GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). Alex: Coming up we talk with three pastoral care workers who are inmates who have been volunteering in the hospice at the California Medical Facility prison for some time. So that touches you.

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IT Family Families Board-Certified 97

Family Medicine Initiative

APRIL 10, 2024

Family medicine is neither the most prestigious nor the highest paid medical profession. million people in 2018), shows that the longer you know your GP, the better off you are. You no longer need to review all medical records or repeat the whole medical and personal history. of healthcare costs in the EU 2018.

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Family Physician Family Families GP 130

GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. And is it at all individualized to the patient? It’s a great question. Yeah, yeah.

Primary Care 80

Primary Care IT Clinic Illness 80

FDA Law Blog

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 18-1156, 2018 U.S. Specifically, in United States v.

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Manufacturing Provider Medical IT 59