FDA Law

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

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Consulting Manufacturing Utilities Provider 52

FDA Law

FEBRUARY 23, 2025

FDA also found that analytical sensitivity and precision testing provided by Abbott was inadequate to confirm the impact of such changes on the clinical performance of its device. Notably, FDAs public WL database only goes back to 2020. This can limit the type of information that can be gained from WLs.

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Manufacturing Provider Consulting IT 64

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care.

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Patients Complication Management Consulting 52

FDA Law

FEBRUARY 1, 2022

And we were even more excited when that release was followed closely by an FDA Report on the comments submitted to FDA in 2020 and 2021 on the listing of patent information in the Orange Book. Finally, several commenters addressed REMS.

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Provider IT Consulting Manufacturing 52

GeriPal

JANUARY 12, 2023

Number four, again, structure and process that promotes early mobilization which may or may not require a formal OT and PT consultation. Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics. That hospital has several affiliate hospitals.

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Hospital Patient-Centered IT Nurse Practitioner 100

PEMBlog

SEPTEMBER 13, 2023

When hypoglycemia is corrected, this etiology has one of the most impressively fast improvements in clinical status. Reaffirmed October 17, 2020 Riviello JJ Jr, Ashwal S, Hirtz D, et al; American Academy of Neurology Subcommittee; Practice Committee of the Child Neurology Society. 2000; 55(5):616-623.

Patients 52

Patients Screening Illness Physicals 52

GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. You can do this many different ways, but the first one is a little bit more structured, like an assessment that we’re all familiar with clinically.

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GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Summary Transcript Summary Diabetes is common.

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Diabetes Management Patient-Centered Family 73

Physician's Weekly

JUNE 19, 2025

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. The AMA points out that doctors must have more schooling and significantly more clinical experience than nurse practitioners. “Hello. How are you feeling?”

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Nurse Practitioner Family Families Primary Care 52

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. Consultations versus telehealth. But watch out! That’s what I’m waiting for, Alex.

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Telehealth Patient-Centered IT Patients 105

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. She also serves as Pillar Co-Lead for Community Engagement at NYU Langone’s Institute for Excellence in Health Equity.

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Community Patient-Centered Mental Health Board-Certified 52

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. And not just statistically significant, but clinically meaningful. So, the docs actually wrote orders for tests, medications, consults.

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Patient-Centered IT Illness Patients 122

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.

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Patient-Centered Hospital Patients IT 132

GeriPal

DECEMBER 8, 2022

So those questions we ask when we’re doing a palliative care consult. And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be.

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Patient-Centered Illness Healthcare IT 115

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a clinical decision support? Long overdue.

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Patient-Centered IT Hospital Patients 77

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.

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Clinic Provider Individual IT 59

GeriPal

FEBRUARY 13, 2025

You did a rural tele-palliative care consultation study. And so the video consult was what became the mode. Marie 03:42 So probably the most important thing is we developed the consultation as a culturally based consultation process. And then we incorporated that information into the consultation process.

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Consulting Community Patient-Centered Family 63

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. That was January 2020. Emily 03:59 Medicine is both a science and an art.

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IT Community Patients Family 107

GeriPal

NOVEMBER 3, 2022

Susan Block had reached out to me and asked if I could contribute something specifically on the experience during the peak months in New York City and COVID Pandemic in 2020. And then to see her show up in our hospice unit in April of 2020, it just completely broke my heart. She was homeless.

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