FDA Law Blog

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

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Clinic Relationship Provider IT 64

Vida Family Medicine

JUNE 28, 2024

Often patients tell me that they have struggled to find a doctor to help them or that previous doctors have dismissed or minimized their symptoms, or have not recommended any additional work-up after initial test results were normal. There are many factors that make it a challenge to get answers for unexplained symptoms. More on that below.

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Patients Primary Care Appointment Diagnose 52

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. Transcript.

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IT Screening Hospital Clinic 102

GeriPal

DECEMBER 2, 2022

He wrote a book titled “ Psychiatric consultation in long term care ” that has a strengths based approach to staging dementia (how cool is that). She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. Summary Transcript Summary. Judy: Thank you. Alex: Great.

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Community IT Individual Patient-Centered 101

GeriPal

NOVEMBER 9, 2023

Alex: We’re delighted to also welcome Greg Pawlson, who’s Senior Faculty at Lodestar Consulting & Executive Coaching and former President of the American Geriatric Society. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? This is Eric Widera.

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Board-Certified IT Primary Care Referral 110

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? Listen in to learn more! Nadine: I do.

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Diabetes Management Patient-Centered Families 74

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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Patient-Centered Manufacturing Clinic Provider 52

GeriPal

JUNE 12, 2025

I’m sort of seeing them in clinic for consideration of palliative radiation, they have a lot going on. Anish 00:24 Thanks so much for having me. Alex 00:26 And we’re delighted to welcome Emily Martin, who is a palliative care doc at UCLA. Emily, welcome to GeriPal. Emily 00:32 It’s good to be here. Evie, welcome to GeriPal.

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Patient-Centered Referral Patients IT 102

Plum Health

OCTOBER 11, 2024

Have you ever found yourself in need of medical attention but overwhelmed by the myriad of clinics and healthcare options out there? This guide will help you understand the different types of clinics and services they offer, so you can make an informed decision about where to seek medical care. It's a common challenge many people face.

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Clinic Primary Care Doctor Primary Care Chronic Condition 52

GeriPal

FEBRUARY 2, 2024

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. Panelists Kate Courtright and Scott Halpern have no relationships to disclose. and consulting for Papa Health.

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Consulting Hospital Patient-Centered IT 121

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. Summary Transcript CME Summary It is a battle royale on this weeks GeriPal podcast.

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Telehealth Patient-Centered IT Patients 105

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. “You want someone who can monitor patients’ side effects and have a longitudinal relationship with them.” That’s according to two internists who work closely with hospitalized patients who take GLP-1s.

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Hospital Management Diabetes Patients 66

GeriPal

JANUARY 25, 2024

Panelists David Bekelman, Lyndsay DeGroot, and Diah Martina have no relationships to disclose. MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 ABIM MOC credit will be offered to subscribers in November, 2024. Welcome to GeriPal, Lyndsay.

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Patient-Centered IT Illness Patients 122

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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Screening IT Families Family 120

GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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IT Patient-Centered Healthcare Illness 105

GeriPal

AUGUST 29, 2024

Alex 01:24 And Elise Carey, who’s a palliative care doc and geriatrician and associate professor of medicine at the Mayo Clinic in Rochester, Minnesota. We must often deliver complex medical information that carries heavy emotional weight in pressured settings to individuals with varying cultural backgrounds, values, and beliefs.

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IT Illness Families Family 132

GeriPal

JANUARY 18, 2024

Panelists Katie Fitzgerald Jones and Jessica Merlin have no relationships to disclose. Alex: We are delighted to welcome back to the GeriPal podcast, Katie Fitzgerald Jones, who’s a nurse scientist at the New England Geriatric Research Education and Clinical Center, and a palliative and addiction nurse practitioner at the VA in Boston.

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Illness Patient-Centered Screening Clinic 136

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*.

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Diabetes Board-Certified Telehealth Government 52

GeriPal

JUNE 15, 2023

Alex: And joining us via Zoom, we have Charlotta Lindvall, who is a palliative care physician researcher who studies the intersection of natural language processing and communication data at Dana Farber Cancer Institute, where she also works in clinical informatics. I’m sure this is a subject we will return to, given the rapid progress on AI.

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IT Patient-Centered Patients Healthcare 99

GeriPal

FEBRUARY 15, 2024

Panelists Carmen Quatman and Katie Quatman-Yates have no relationships to disclose. Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. Alex: I think this is a first.

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Community Transportation IT PCP 115

GeriPal

JANUARY 16, 2025

I, for example, had one patient, I remember during my fellowship, I was in geriatrics clinic and had a very well read patient who came in and was reading a New York Times article, I think in the well section at one point. Alex 02:21 For Eric 02:21 For unrepresented older adults. Tim 02:29 Yeah, it’s such an honor to make a song request.

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Patient-Centered IT Patients Healthcare 109

GeriPal

FEBRUARY 23, 2023

Rather, most of us live and make decisions in relationship to one another. Today we talk with Anne Rohlfing, Lynn Flint, and Anne Kelly, authors of a JGIM article on the reasons we shouldn’t stop at “no.” We owe it to the patient to explore the reasons behind the “no,” commonly not wanting to be a burden to their family. Yeah, exactly.

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Families Family Patient-Centered IT 98

GeriPal

JUNE 19, 2025

Eric and I remember him from that time and he’s now at the University of Nevada, Las Vegas, where he is associate professor in the department of social and behavioral health. Jace, welcome to the GeriPal Podcast. Jace 00:37 Thank you so much, Alex and Eric, it’s nice to be here with you. Eric 01:21 Why’d you choose this song?

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Individual Community IT Chronic Condition 82

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

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Patients Clinic Patient-Centered Illness 73

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107

GeriPal

SEPTEMBER 22, 2022

And I think also some of the stuff we’ll be talking about, when it comes to communication, I mean, a lot of the clinical encounter is listening to the music. Coming off as rote and scripted during a serious illness conversation can have a similar off-putting impact on patients and families. Key message: Listen to the music. All right.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

DECEMBER 8, 2022

Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. It wasn’t until the end that the best term emerged – storycatching. It’s since spread to over 70 VAs.

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Patient-Centered Illness Healthcare IT 115

The Clinical Problem Solvers

FEBRUARY 8, 2023

One example that is presented involves the complicated relationship between the United States and Chinese immigrants and farmworkers in California. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JUNE 5, 2025

Cari 01:42 I would like to request Hallelujah, one of my favorite songs. And I love hearing you sing, and so it’s an excuse to have you sing a beautiful song. And it’s, I think, a very uplifting song. And I’m so pleased with Connie and that she’s doing so well, and so it’s a celebration of her, too. No problem.

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Nurse Practitioner Referral Consulting Board-Certified 78

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. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC.

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Patient-Centered IT Hospital Patients 77

GeriPal

NOVEMBER 21, 2024

Acceptance. All of these are ways we cope with stressful situations. Some we may consider healthy or unhealthy coping strategies, but are they really that easy to categorize? Isn’t it more important to ask whether a particular coping behavior is adaptive or not for a particular person,in a particular time or situation? Amanda, welcome to GeriPal.

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Illness IT Patient-Centered Patients 125

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. Widera and Smith have no relationships to disclose. Guest Laurie Dornbrand has no relationships to disclose. ” Eric: That was lovely.

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Families Family Patient-Centered IT 112

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. Welcome back, Ashwin. Alex: Great.

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IT Community Patient-Centered Medical 99

GeriPal

APRIL 28, 2022

Graphic Novels. Graphic Medicine. I’m not sure what to title this podcast but I’ve been looking forward to it for some time. Heck, I’m not even sure to call it a podcast, as I think to get the most out of it you should watch it on YouTube. Why, because today we have Nathan Gray joining us. Transcript. Eric: Welcome to the GeriPal podcast.

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IT Hospital Patients Illness 145

GeriPal

MAY 4, 2023

We talk about why it’s so hard with Abby Rosenberg (chief of PC at DFCI and Boston Childrens), Nick Purol (clinical social worker at DFCI and Boston Childrens), Daniel Eison (pediatric PC doc and co-host of PediPal). But when I have, I find that they’re often some of the hardest patients to care for. Welcome to the GeriPal podcast, Abby.

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IT Families Family Illness 83

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 Families 63

GeriPal

MARCH 13, 2025

Justin Sanders wants to be sure the newer generations of palliative care clinicians understand the early principles and problems that animated the founders of hospice and palliative care, including: Origins of the word palliative – its not what I thought! If you read just one, read Palliative Medicine – Just Another Specialty ?

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IT Patient-Centered Families Family 104