FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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Clinic Clinical Practice Provider Utilities 64

Sound Physicians

NOVEMBER 19, 2024

With a clinical population as large as ours, one of our greatest assets is our national footprint. Bringing our leaders together for interactive leadership development is paramount to maintaining clinical practice excellence across our partnerships.

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Hospital Telemedicine Clinic Management 52

GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. Alex 14:45 And is it ethical to do a placebo taper in real world clinical practice? Ethical and practical. Eric 15:32 Could do this in clinical practice. I guess those are the questions.

Specialization 119

Specialization IT Patient-Centered Medical 119

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not.

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IT Screening Hospital Clinic 102

GeriPal

MARCH 14, 2024

But again, most of my clinical practice, until recent years, has been in the acute care setting. We don’t have to go into that, but I do want to highlight, you had a JAGS article that was published on pre-hospitalization dysphagia and feeding tube placement in nursing home residents with advanced dementia. Eric: Great.

IT 124

IT Patient-Centered Hospital Individual 124

GeriPal

JANUARY 12, 2023

If you want to do a deeper dive in ACE units, check out some of the following articles: The original NEJM paper on ACE units from 1996. What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? Kellie: Yes. Eric: What do you think, Kellie? Any other thoughts? Kellie: Yeah, I agree.

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Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

JULY 19, 2024

There’s an article about her in New York Times. And this is, of course, an old and foundational idea about clinical practice. But it seems very apropos to the topic. Soo 01:37 It’s a little obvious. Anna 01:38 Yeah. Alex 01:38 And I love that Sarah McLaughlin’s having a comeback. She’s doing a tour.

Screening 119

Screening Primary Care Patient-Centered IT 119

Common Sense Family Doctor

MAY 30, 2025

A 2023 Cochrane for Clinicians article found similar benefits but also noted that for every 10,000 people screened, 363 unnecessary invasive tests are performed.

Primary Care 59

Primary Care Screening Family Physician DO 59

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. Source: cghjournal.org/article/S1542-3565(25)00460-4/abstract The post Social Risk Burden and Its Impact on Healthcare Use in IBD first appeared on Physician's Weekly.

Healthcare 52

Healthcare Transportation IT Insurance 52

GeriPal

APRIL 4, 2024

In case you miss the introductions at the start of the podcast, Bernie and Laurie are married, and offer wonderful reminiscence of their clinical practice over the last several decades. You write about this, you’ve written this New England Journal article, you’ve written past articles.

Family 112

Family Families Patient-Centered IT 112

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Stacy: I honestly read Michael Pollan’s New Yorker article and was really inspired, and cold emailed the group at NYU, and they responded. Theora: Bryan shared that article with me. Eric: Yeah.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

MAY 25, 2023

I’m not sure if you read that article and whether or not it’s changed your mind or whether or not you want to do any more research in advance care planning. And as you know, it’s a great article. And I know a lot of our social work colleagues and our nurses, I think at least in our practice, do a lot more of that.

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

FEBRUARY 6, 2025

They actually published a really good article in December on what’s the role, how should we diagnose Alzheimer’s disease in primary care? Eric 42:02 I want to ask, because I’m going to bring to your last article that I was just reading last night again, which I thought was fabulous. Beautiful flowcharts.

Primary Care 96

Primary Care Diagnosis Screening IT 96

GeriPal

JANUARY 18, 2024

We got a couple of articles to discuss and a lot of different components of this. Eric: Which brings us to an article. And so, we ultimately kept him on in palliative care clinic for a while. [laughter] Eric: Okay, Katie, we’ve got a lot to cover with substance use disorder. Jessie: Exactly. Eric: Oh, you were? Eric: Yeah.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

AUGUST 24, 2023

And I had no idea what that would look like or what I would do until I happened upon an article by actually a fellow Winnipegger, a man named Jim Brown who was an expert in mood disorders. And decided, interesting article, but it raised as many questions as it answered. ” And we began writing and we got our first grant.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. We discuss an article they wrote about PULET for the American Journal of Hospice and Palliative Medicine, including: What makes a PULET a PULET? Ivermectin to treat cancer.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

FEBRUARY 29, 2024

The ones who are publishing interesting articles are easy as we knew MAID is always going to be a controversial topic. Anne: Which episode of the GeriPal podcast has most significantly changed your clinical practice? So, we did try to get some breadth of guests on our show. We mentioned her name before.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

SEPTEMBER 1, 2022

So in preparation for this, I read a couple articles about social work leadership in palliative care. And the title of his article is, does culture of modern day palliative care social work leave room for leadership, where he interviewed six leaders in palliative care, five or six for social workers. Eric: All right, Barbara.

IT 102

IT Family Families Clinic 102

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. To learn more about CME for other GeriPal episodes, click here.

IT 67

IT Patient-Centered Individual Patients 67

GeriPal

OCTOBER 19, 2023

Additional links mentioned in the podcast: Recent JGIM article on POLST in California nursing homes, hospitalization, and nursing home care Karl’s GeriPal post on appropriate use of POLST Enjoy! Respectful disagreement is in short supply these days. OK, I’ll step off my soap box. AlexSmithMD Transcript Eric: Welcome to the GeriPal podcast.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

GeriPal

APRIL 13, 2023

Ashwin Kotwal: Yeah, and Thomas, I know this is something we’ve talked about as a group too, which is how do you translate some of these scales that we use in large studies to our clinical practice? I’m wondering, you talked about that patient who was really isolated and coming to the emergency room. It’s tough.

IT 99

IT Community Patient-Centered Medical 99

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. But that was my take home from Danny’s article. Eric 07:23 I’m guessing that there was some of this going on where you work, because you actually created a clinic around this particular population.

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Patients Clinic Patient-Centered Illness 73

GeriPal

MARCH 20, 2025

To delve into these questions, we spoke with Hope Wechkin, medical director of EvergreenHealth home hospice, who authored an article describing a process of Minimal Comfort Feeding (MCF) for patients who have expressed an interest in not wanting to live with advanced dementia. Thaddeus, you wrote an article in JAGS not too long ago.

IT 88

IT Patient-Centered Patients Medical 88

GeriPal

MARCH 10, 2022

And to keep it short work for an article. Joan: A lot of my work comes out of my clinical practice. And I again, reference the readers back to this JAMDA article where we proposed a concerted coordinated framework for achieving an integrated model of palliative care in nursing homes. Ruth: Mm-hmm (affirmative).

Nurse Practitioner 60

Nurse Practitioner Hospital Family Families 60

GeriPal

JULY 13, 2023

[laughter] Bob: That’s what happens when junior faculty get invited on the podcast [laughter] Eric: So we’re going to be talking about the article that just came out in JAMA on a priming intervention for goals of care conversations in hospitalized patients with serious illness. We’ll have a link to the article on our notes.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. But before we dive into the study and the implications it has for the practice that we do, I believe someone has a song request. Outcomes are typically assessed from available records.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

GeriPal

DECEMBER 1, 2023

This is directly from their article draft, which we’ll have on our website: Beta-amyloidosis, having amyloid in your brain or in high levels in your plasma defines the initially detectable stage of Alzheimer’s disease. Specifically their position is beta-amyloidosis.

IT 116

IT Clinic Illness Hypertension 116

GeriPal

JUNE 6, 2024

Here are some articles that Kira and I have written about the topic, and that’s really how my interest in addressing sexual health concerns started. And so we have basic treatments for these issues that we train oncology clinicians to bring up in clinic practice. And I work right next to Don at the time.

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Illness IT Physicals Patients 130