FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

33 Charts

OCTOBER 2, 2021

And as suggested recently in the New England Journal of Medicine , One of the most important factors at play in the clinical environment is the apparent tension between availability and attention. Some will convert their practice into a virtual clinic with late night pajama time ‘sessions’ while others will recognize the need for guardrails.

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Patients IT Provider Family Doctor 75

FDA Law Blog

JUNE 29, 2022

It explains that “FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., randomization, blinding).” Total Requests Received. Granted . Rescinded .

IT 52

IT Clinic Provider Medical 52

Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. He replied, “Yes.” So what’s the real issue?

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

GeriPal

JUNE 19, 2025

Noelle Marie 01:24 I think it really speaks a lot to my own personal journey and I’m pretty sure a lot of trans and gender diverse individuals also resonate with and it really speaks about our transition, celebrating our authentic selves, how society views us and how we view ourselves when we stand in front of a mirror.

Individual 82

Individual Community IT Chronic Condition 82

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. Who do we have with us today? Katie, welcome back to GeriPal.

Illness 137

Illness Patient-Centered Screening Clinic 137

GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. So in those clinical situations, you should consider avoiding that drug. You have to take that into consideration clinically. Mike: Thanks for having me.

Medical 97

Medical IT Patients Clinic 97

GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers. And then the second one in 2015.

IT 100

IT Community Patient-Centered Medical 100

GeriPal

DECEMBER 8, 2022

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. Working with our clinical decision support team and thinking about where that could be. Journal of Palliative Medicine , 23 (6), [link].

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. I understand that it can be a hard place clinically. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin).

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 15, 2022

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. Working with our clinical decision support team and thinking about where that could be. So I would love to hear.

IT 106

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. 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.

Patient-Centered 133

Patient-Centered Hospital Patients IT 133

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. Samir: Thanks, Alex and Eric.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

DECEMBER 14, 2023

Similarly Jessica Zitter, an intensivist and palliative care doctor analogized the inevitable clinical momentum toward highly aggressive intensive care in US hospitals as a conveyor belt. Liz: Well, some aspects of this paper around clinical momentum and things around defaults and that sort of thing. Liz: I do, indeed. Proud Mary.

Hospital 126

Hospital IT Patient-Centered Patients 126

GeriPal

MARCH 3, 2022

Julien, let’s start off with, congratulations by the way and Lauren too, the CHEST paper that just got published on Trends in Geriatric Conditions Among Older Adults in the ICU between 1998 and 2015. Lauren: Although again, still thinking about what that means for an individual older adult is really important.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

JANUARY 11, 2024

Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. The MAID issue then came on the table in Canada after the 2015 Supreme Court ruling in Carter v. So it started off for individuals with a terminal illness. Bill: Thank you.

Illness 144

Illness IT Medical Provider 144

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. My interest in this paper and this topic goes back a long time and is based on my clinical experience as a hospice nurse, where I was taking care of what I felt like and what we’ve confirmed with research is about half of my patients.

Families 107

Families Family IT Patients 107

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. Voting and emailing congress to advocate for systemic change (e.g.

Healthcare 130

Healthcare IT Education Community 130

GeriPal

JULY 25, 2024

Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? The folks that we were seeing either in clinic or inpatient, were probably a lot sicker than the ones that we’re seeing now.

Families 108

Families Family Patient-Centered Patients 108

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. I think the big one for me, it was in 2015.

Patient-Centered 126

Patient-Centered IT Families Family 126

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.

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Utilities IT Engineering Appointment 64