FDA Law Blog

AUGUST 22, 2023

On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots ! By Dara Katcher Levy — OPDP is coming out ! So, what gives? NAD appeared to be inviting pharmaceutical companies to leverage its processes and submit complaints.

Healthcare Professional 40

Healthcare Professional Healthcare IT Complication 40

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. I do like that one.

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IT Patient-Centered Patients Clinic 120

GeriPal

MARCH 14, 2024

Some of our healthcare systems are hard, and challenging, and I think that it’s time that we have a change. Some of our healthcare systems are hard, and challenging, and I think that it’s time that we have a change. Eric: Alex, we got a great show today on Dysphagia Revisited. Who do we have on with us today? Eric: Oh boy.

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IT Patient-Centered Hospital Individual 124

GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

Screening 119

Screening Primary Care Patient-Centered IT 119

GeriPal

JANUARY 12, 2023

After coming out of residency and taking care of lots of complicated older adults as of now, a brand new physician attending, I really needed that team to help me out. Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . I think Kellie, do you have it?

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Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

MAY 11, 2023

Kristine, do you have a song request for Alex? Kristine: Well, I did have a song, but I was negligent at giving it to him. So, he tried to read my mind… Eric: What was your song? Kristine: I was going to do David Bowie Changes for a variety of reasons, but it was sort of somewhat around the topic. Alex: (singing) Eric: That was wonderful.

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Physicals IT Hypertension Education 85

GeriPal

JUNE 8, 2023

We debate the merits of use of CGM in the nursing home and other late life settings (Eric and I argue against CGM and lose). Ozempic is a new fancy med that, by the way, leads to weight loss among celebrities, resulting in shortages of the drug from people using it off-label for that purpose. Listen in to learn more! This is Eric Widera.

Diabetes 73

Diabetes Management Patient-Centered Family 73

GeriPal

JUNE 12, 2025

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. Alex 00:33 And delighted to welcome Evie K a lmar, who’s a geriatrician and palliative care doc at UCSF. 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? Navigating the healthcare system can be daunting, especially when you're unwell or caring for someone who is. It's a common challenge many people face.

Clinic 52

Clinic Primary Care Doctor Primary Care Chronic Condition 52

Rao Doctor

APRIL 3, 2025

This information can help pinpoint possible causes of illness and guide further investigations. Using these methods can reduce temperature discomfort and minimize complications. In my previous article I covered the types of illness and the causes. A comprehensive history includes: A body temperature exceeding 100.4°F

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Diagnosis Management Illness Diagnose 130

Doctor On Demand

APRIL 28, 2025

In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Most sore throats are common cases, so it can be hard to know when to seek urgent care or when to just rest at home.

ER 52

ER Telehealth Primary Care Doctor Appointment 52

GeriPal

OCTOBER 24, 2024

Summary Transcript CME Summary Cannabis is complicated. It can mean many things, including a specific type of plant, the chemicals in the plant, synthetic analogs, or products that have these components. Eric 00:49 And I just want a big shout out to Alex Gamble, who said, we have to get Eloise on a podcast to talk about this topic.

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Medical IT Patient-Centered Healthcare 98

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. And one of the hardest things is to distill it down to a sentence or two about what is information, what does it mean? It’s titled the VitalTalk Method.

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IT Illness Families Family 132

GeriPal

JUNE 27, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Summary Transcript Summary “Anxiety is a lot like a toddler. It never stops talking, tells you you’re wrong about everything, and wakes you up at 3 a.m.” Alex Gamble, do you have a song?

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Illness IT Diagnosis Patient-Centered 129

GeriPal

FEBRUARY 15, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. Their job was done. This is a first for our GeriPal podcast, right, Alex?

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Community Transportation IT PCP 114

GeriPal

JANUARY 25, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 Welcome to GeriPal, Lyndsay. Is it you Lyndsay?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

NOVEMBER 14, 2024

And the big things that we think about as far as complications, so there, obviously the thing that comes to everybody’s mind is like fractures. Sarah 00:37 Ooh, how about Free Fall in’? Alex 00:41 Free Fall in’? Alex 00:45 We did this, like one of our first podcasts, I r emember, and second verse, I kind of went for it. Alex 04:10 Wow.

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IT Patient-Centered Screening Community 124

GeriPal

SEPTEMBER 7, 2023

Summary Transcript Summary The comprehensive geriatric assessment is one of the cornerstones of geriatrics. But does the geriatric assessment do anything? Does it improve outcomes that patients, caregivers, and clinicians care about? We talk about: What is a practical geriatric assessment and how can busy oncologists actually do one? Thank you.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

JUNE 15, 2023

Hallucinations, or when the AI lies or b *s, then denies it When the AI approaches sentience, is it ethical to unplug it? I’m sure this is a subject we will return to, given the rapid progress on AI. But then it asked me, “Oh, that sounds really interesting. Who are you going to be talking to?” ” And I said, “Sure.”

IT 99

IT Patient-Centered Patients Healthcare 99

Vida Family Medicine

JUNE 29, 2022

The healthcare system must provide care in a just way so that those who need care have access to it. This is relatively easy for straightforward medical decisions like taking an antibiotic for an infection, but becomes complicated during more complex situations.

Family Physician 52

Family Physician Family Families Healthcare Professional 52

GeriPal

JULY 21, 2022

Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is. Eric: What’s the song? Emmy: I just forgot the name of the song… [laughter]. Alex: Pink Cadillac by Bruce Springsteen? I like that song.

IT 102

IT Family Families Diagnosis 102

GeriPal

FEBRUARY 23, 2023

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. And I’m worried that there may come a time when you have trouble making decisions for yourself.

Family 97

Family Families Patient-Centered IT 97

GeriPal

JULY 11, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Summary Transcript Summary In May we did a podcast on KidneyPal (the integration of palliative care in renal disease) , which made us think, hmmm… one organ right next door is the liver.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

GeriPal

MAY 22, 2025

We start each podcast with a song in part to shift the frame, taking people out of their academic selves and into a more informal conversation. Summary Transcript CME Summary As you know, dear listeners, I love music. Well, todays guests love music at least as much if not more than me, and they each make a strong case for music as medicine.

IT 96

IT Patient-Centered Patients Board-Certified 96

GeriPal

MARCH 9, 2023

Eric, did you take your ketamine before this podcast? Eric: No, I did a little psilocybin. Eric: Thanks to our Ira Byock podcast. I forget how long ago that was. Alex: Yeah, it’s time to update, psilocybin is having a moment. We’re going to talk about that. Welcome back to GeriPal, Stacy. Stacy: It’s great to be here. Alex: Yeah.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

FEBRUARY 8, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 Naomi: Yes, I do. Everybody Hurts by REM.

IT 137

IT Families Family Physicals 137

GeriPal

SEPTEMBER 28, 2023

Summary Transcript Summary Medical communication is tough, although fundamentally at its most basic unit of delivery, it includes really only three steps. First, a clinician’s thoughts must be encoded into words, then transmitted often via sounds, and finally decoded back to thoughts by a patient or family member. Simple, right? Alex: (Singing).

Family 144

Family Families Patient-Centered IT 144

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.

Illness 125

Illness IT Patient-Centered Patients 125

GeriPal

JUNE 30, 2022

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? You have a patient with dementia severe enough that she cannot recognize relatives. She falls and breaks her hip. Should she be treated non-operatively, with aggressive symptom management? It was Remember Me.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

JUNE 16, 2022

There are a lot of old myths out there about managing urinary tract symptoms and UTI’s in older adults. For example, we once thought that the lower urinary tract was sterile, but we now know it has its own microbiome, which may even provide protection against infections. But before we get into this topic, does someone have a song request?

Management 122

Management IT Medical Patient-Centered 122

GeriPal

OCTOBER 12, 2023

And, what if your surgeon openly discussed the expected ‘bad stuff’ of post-operative recovery, instead of rotely reciting a list of possible complications? Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. Justin, welcome to GeriPal. Justin: Hello. Eric: Okay.

IT 128

IT Families Family Patient-Centered 128

GeriPal

MAY 4, 2023

We in geriatrics and adult palliative care clinicians have so much to learn from our colleagues in pediatrics – and though many of these lessons are specific to adolescents and young adults – many of the lessons are valuable for the care of patients in older life stages. Why does it feel different? Does it feel different? Abby: I do.

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IT Family Families Illness 83

GeriPal

OCTOBER 26, 2023

Ann: Well, I think teamwork is key in this space and I am a big baseball fan, big Red Sox fan, which is not a good thing to be right now, but I really think it’s indicative of how we should all be working together on this team to help our seriously ill patients. Ann: No, he was very excited. And this time everybody’s joining in.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

MARCH 24, 2022

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness 72

Illness IT Healthcare Patient-Centered 72

GeriPal

MAY 26, 2022

The basis of their argument is the ethical notion of “reciprocity” – people who are vaccinated have done something to protect the public health, and we owe them something for taking that action. Eric and I attempt to poke holes in their arguments, resulting in a spirited discussion. Evusheld is the latest case in point. . Alex: Love this.

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Vaccination Individual IT Healthcare 87

GeriPal

NOVEMBER 7, 2024

Or is it just this lingering practice of starting dialysis early before really severe complications develop? Do target trials differ from randomized trials and “ordinary” observational studies, or do they differ?!? Eric is skeptical. Bottom line: if faced with the decision to initiate dialysis, waiting is generally better. Well, I got.

Management 116

Management Patient-Centered Patients IT 116

GeriPal

MAY 15, 2025

At one end of the spectrum you can provide decision makers with information that doesn’t work very well in most contexts. The nudge toward offering comfort care led to more hospice and early comfort-care orders. Is this due to chance alone, given the multiplicity of secondary outcomes examined? Where was it? We also had a podcast with.

Patient-Centered 116

Patient-Centered Hospital IT Illness 116