FDA Law

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

FDA Law

SEPTEMBER 20, 2021

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

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 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.

IT 102

IT Screening Hospital Clinic 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.

Clinic 52

Clinic Primary Care Doctor Primary Care Chronic Condition 52

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.

Diabetes 73

Diabetes Management Patient-Centered Families 73

GeriPal

JUNE 12, 2025

I’m sort of seeing them in clinic for consideration of palliative radiation, they have a lot going on. So you have the consultation. Eric 27:57 And for those, does everything just condense as far as consultation, simulation and dose? Eric 00:59 Why did you choose this song? Procedure as well as the treatments.

Patient-Centered 102

Patient-Centered Referral Patients IT 102

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.

Consulting 120

Consulting Hospital Patient-Centered IT 120

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! Alex 01:06 Yeah, go in person.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

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

Panelists David Bekelman, Lyndsay DeGroot, and Diah Martina have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. And not just statistically significant, but clinically meaningful. Eric: Yeah.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

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.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. Panelists Katie Fitzgerald Jones and Jessica Merlin have no relationships to disclose.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

FEBRUARY 23, 2023

Rather, most of us live and make decisions in relationship to one another. And then we were involved, palliative care was consulted when the patient was really sick and decompensating in the ICU. But once we realize that almost everybody makes decisions in the context of relationships. That can all start with you.”

Family 97

Family Families Patient-Centered IT 97

GeriPal

AUGUST 29, 2024

We must often deliver complex medical information that carries heavy emotional weight in pressured settings to individuals with varying cultural backgrounds, values, and beliefs. 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.

IT 132

IT Illness Families Family 132

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.

Screening 119

Screening IT Families Family 119

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. So those types of relationships, clergy, non family members, we talk about, I think cohabitating unmarried couples.

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

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. Welcome to the GeriPal podcast, Charlotta. Charlotta: Thank you.

IT 99

IT Patient-Centered Patients Healthcare 99

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. Tell me about the clinical enc… How do you think the uncanny valley fits into medicine and communication training and skills? What is the uncanny valley? Eric: Yeah.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

FEBRUARY 15, 2024

Panelists Carmen Quatman and Katie Quatman-Yates have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. They may not think to ask or provide that information. Sometimes it’s unskilled things.

Community 114

Community Transportation IT PCP 114

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?

Patients 72

Patients Clinic Patient-Centered Illness 72

GeriPal

APRIL 4, 2024

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Widera and Smith have no relationships to disclose. Guest Laurie Dornbrand has no relationships to disclose.

Family 112

Family Families Patient-Centered IT 112

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.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

JUNE 5, 2025

And so we do have consultants who come in the building. And usually it’s simply for a consultation. And, you know, some, some relationship with hospice, some might not do many referrals at all to hospice. Some will have stronger relationships with hospice. But we, we do a lot of, a lot of care in the facility.

Referral 78

Referral Nurse Practitioner Consulting Board-Certified 78

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.

Consulting 63

Consulting Community Patient-Centered Families 63

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. So when they do meet it, how are you going to be in relationship to it?

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

NOVEMBER 21, 2024

The clinical trials and the this and that. Potentially harmful elements of that coping mechanism for your relationship with your four year old. As much information and control I can give, I’m going to give because I think that this coping is helping them stay rooted. They’re doing. They’re doing.

Illness 125

Illness IT Patient-Centered Patients 125

GeriPal

JUNE 19, 2025

Jace 30:29 For a long caregiver challenges and not, you know, having to go into spaces that are heavily like hetero and cis normative in terms of how they provide services, how they navigate relationships. But you know, the clinical piece, I think it starts out with collecting sexual orientation, gender identity in your databases.

Individual 85

Individual Community IT Chronic Condition 85

GeriPal

OCTOBER 5, 2023

And I have gone through my not-so-long career, but it’s coming up on nine years now, seeing the way that we have talked about CPR in such problematic ways, in ways that really do not enable true informed consent. I point this out a lot more nowadays to the resident teams that consult. But we gave it as an option. Sunita: I know.

Illness 136

Illness IT Patient-Centered Families 136

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.

IT 83

IT Families Family Illness 83

FDA Law

JANUARY 8, 2023

Doctor-Patient Relationship. The Act requires DEA, in consultation with HHS, to assess annually whether an adequate and uninterrupted supply, down to specific strains, exists and to establish sufficient quotas to ensure an uninterrupted supply. Adequate and Uninterrupted Supply of Cannabis. 21 U.S.C. §

Medical 64

Medical Manufacturing Electronics Provider 64

GeriPal

JANUARY 11, 2024

** Claim your CME credit for EP293 “What’s Up With MAID in Canada” [link] Note : If you have not already registered for CME, you can register here [link] For more info on the CME credit, go to [link] Disclosures: Moderators Drs Widera and Smith have no relationships to disclose. Bill, welcome back to GeriPal.

Illness 144

Illness IT Medical Provider 144

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. Years and years ago, the first few years as an attending physician, I was consulted to take care of a gentleman with metastatic esophageal cancer. Ivermectin to treat cancer. Chelation therapy.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

MARCH 7, 2024

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. Eric: When I try to think about what a doula does, should I call it a consult? John: Yeah.

Provider 117

Provider Illness IT Healthcare 117

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 125

Hospital IT Patient-Centered Patients 125

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. Jennifer 07:31 From.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” Widera and Smith have no relationships to disclose.

Patient-Centered 128

Patient-Centered IT Patients Consulting 128

GeriPal

APRIL 26, 2024

Widera and Smith have no relationships to disclose. Guest Betty Ferrell has no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. I was a clinical ethics fellow at Baylor College of Medicine.

Patient-Centered 119

Patient-Centered IT Patients Consulting 119