FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

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Clinic IT Provider Patient-Centered 59

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.

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Manufacturing Hospital Healthcare Medical 81

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. AMA PRA Category 1 credit(s) ™. Katie, welcome back to GeriPal.

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Illness Patient-Centered Screening Clinic 137

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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Patient-Centered Illness Healthcare IT 116

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. So I would love to hear.

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IT Patient-Centered Healthcare Illness 106

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. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility. Dear listeners, if you have a podcast idea, feel free to reach out to us.

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Patient-Centered Hospital Patients IT 133

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. Tasce: Yes. Taylor Swift.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JUNE 19, 2025

It was also the time that in 2015, that people who were trans and famous really put being trans on the map at that time, too. Knowing that the community is really underrepresented in sort of our knowledge, what we do, how we provide care that’s truly inclusive and welcoming. – Rainbows of Aging : Jace Flatt’s research site.

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Individual Community IT Chronic Condition 82

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? And then the second one in 2015. I moved to Baltimore in 2015 and did clinical fellowship in geriatrics.

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IT Community Patient-Centered Medical 100

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

DECEMBER 14, 2023

More recently Sharon Kaufman ‘s book And a Time to Die described the ways in which physicians, nurses, hospital systems, and payment mechanisms influenced the hour and manner of patient’s deaths. Liz: Well, some aspects of this paper around clinical momentum and things around defaults and that sort of thing. Proud Mary.

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Hospital IT Patient-Centered Patients 126

PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2015 Apr;22(4):441-6.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary.

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Illness IT Medical Provider 144

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.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Ruth, welcome to GeriPal.

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Healthcare IT Education Community 130

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. Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Why do this? AMA PRA Category 1 credit(s) ™. Liz 01:04 I do have the song.

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Families Family Patient-Centered Patients 108

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.”

Patient-Centered 126

Patient-Centered IT Families Family 126

Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. Pamela Wible soon discovered why. Let’s hear it for you guys.

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Clinic Nurse Practitioner IT Medical 246