FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

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Clinic Relationship Provider IT 64

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included.

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Manufacturing Provider Medical IT 98

GeriPal

JANUARY 23, 2025

Summary Transcript CME Summary Its another deprescribing super special on today’s GeriPal Podcast, where we delve into the latest research on deprescribing medications prescribed to older adults. Today, we explore four fascinating studies highlighting innovative approaches to reducing medication use and improving patient outcomes.

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Specialization IT Patient-Centered Medical 119

Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Adler, J.D.,

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Management Telemedicine Insurance Patients 52

FDA Law Blog

MARCH 7, 2022

At this time, FDA is continuing to grant applicants an automatic 360 days to respond to requests for additional information pursuant to its Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised) (June 2020). Devices Marketed Under an EUA.

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Manufacturing IT Relationship Medical 52

FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. More specifically, the prohibition includes when a “third party (e.g., Draft Guidance III.B.1.

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Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

DECEMBER 2, 2022

And for people with dementia and their caregivers, who both feel very devalued in the social system, support systems, their communities, the medical system. This whole conference that Ab puts on, and all of the tools and resources that he provides people and families with dementia are about, how do you build on the remaining strengths?

Community 101

Community IT Individual Patient-Centered 101

GeriPal

JULY 27, 2023

Alex: Here, I thought it was just like a relationship tension and breakup song. And very common symptom or coexists commonly with other health conditions and in medications that are used, impacted. But I’m also thinking about other health conditions and other medications that might be causing them trouble. Thank you, Alex.

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Illness IT Medical Clinic 85

PEMBlog

OCTOBER 2, 2024

Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. This measures both acid and non acid reflux events. So you could start that in the emergency department if the symptoms are severe enough, provided that they have primary doctor follow ups.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia.

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IT Screening Hospital Clinic 102

Dr. Michael Bazel

JUNE 16, 2025

Also Read: The Most Common Respiratory Diseases Affecting Men’s Health When Stress Is the Likely Culprit Sometimes, symptoms are directly tied to life events or mental strain. You might also be referred to your primary care provider, OB/GYN, or an endocrinologist for further evaluation.

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IT Physicals Management Diagnosis 130

The Clinical Problem Solvers

DECEMBER 20, 2021

Appreciate how intergenerational trauma may surface amongst Asian-Americans, and how these intergenerational relationships may also offer fertile ground for generating understanding. provision in only English +/- Spanish), limitations of medical technology (i.e., Anti-Asian hate crime events during the COVID-19 pandemic.

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Community Patient-Centered Relationship Healthcare 52

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. Going into patient’s homes was eye opening. Their job was done.

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Community Transportation IT PCP 114

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care.

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Family Medicine DO Family Families 40

GeriPal

NOVEMBER 7, 2024

And the main topic of today is a paper in Annals of Internal Medicine , Maria first author, that addressed the tradeoffs between initiating dialysis vs continued medical/supportive management. Susan 01:36 To reflect continuing medical management versus starting dialysis, which is what Maria’s wonderful paper goes through.

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Management Patient-Centered Patients IT 116

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. So there’s an event or a series of events. So there’s an event or a series of events. Kate 04:53 As well as how they cope with that event.

IT 66

IT Patient-Centered Screening Patients 66

GeriPal

OCTOBER 17, 2024

Summary Transcript CME Summary When treating heart failure, how do we distinguish between the expanding list of medications recommended for “Guideline Directed Medical Therapy” (GDMT) and what might be considered runaway polypharmacy? He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge.

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Primary Care Patient-Centered IT Patients 113

GeriPal

FEBRUARY 8, 2024

** Claim your CME credit for EP297 “The Nature of Suffering” [link] Note : If you have not already registered for the annual CME subscription ( cost is $100 for a year’s worth of CME podcasts ), 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.

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IT Families Family Physicals 137

Maine Academy of Family Physicians

OCTOBER 22, 2023

6-week Medical Student Externship - Medical Student Externship Report – Molly Mann, MS2 2023 July – August "My externship experience consisted of shadowing Dr. Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. and hear about their programs.

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Medical Student Family Medicine DO Patient-Centered 40

GeriPal

JULY 11, 2024

Widera and Smith have no relationships to disclose. Guests Kirsten Engel, Sarah Gillespie-Heyman, Brittany Waterman, & Amy Johnson have no relationships to disclose. I think for families and for other providers who are not trained in that, it’s very hard to predict. AMA PRA Category 1 credit(s) ™. Brittany 15:07 Right.

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Patient-Centered IT Patients Clinic 109

GeriPal

MAY 22, 2025

You can hear Tyler and I having a great time singing together and sharing stories around his podcast My Medical Mixtape. And I was fortunate to record an episode of my medical mixtape with Tyler at the w hich meeting were we at, Tyler ? And so this is a shout out to our inpatient palliative team at Dell Medical School.

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IT Patient-Centered Patients Board-Certified 96

GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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Healthcare IT Community Illness 100

GeriPal

MAY 29, 2025

I think we have ideas about are these paradoxical events, are they expected? And I think Andrew’s going to have good ideas about, like, why the term paradoxical and are these events paradoxical, truly? This is, you know, has to do with our personal relationship. Andrew could talk about. Do you have like a. I think we all.

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Families Family IT Patient-Centered 93

GeriPal

MARCH 13, 2025

Alex Smith Links Link to the McGill National Grand Rounds Series on Palliative Care , Michael Kearney as initial presenter, and registration for future events. What I think so special about palliative care is that there’s some really radical and important ideas that sort of undergird our work and that provided a foundation for our work.

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IT Patient-Centered Families Family 104

GeriPal

JULY 28, 2022

And so I went into medical school wanting to cure cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. I entered medical school and I did a course that was offered that’s called living with a life threatening illness.

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Illness Hospital Patient-Centered Patients 110

GeriPal

JANUARY 26, 2023

Alex: And we are delighted to welcome Sharon Brangman, who is a geriatrician and chair of the Department of Geriatrics at Upstate Medical University. Then, of course, that falls into medical rules. No need for me to get rid of that pesky J in my name. Welcome to the GeriPal podcast Sharon. Sharon: Thanks for having me.

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IT Patient-Centered Healthcare Patients 91

GeriPal

OCTOBER 5, 2023

Sunita: Honestly, I’d be happy to provide the vocals. And this is someone who had taken very good care of himself, who had recently retired, who his wife said was just meticulous about his medications. We think it’s like the pinnacle of medical heroism. This is Eric Widera. Alex: This is Alex Smith.

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Illness IT Patient-Centered Families 136

GeriPal

SEPTEMBER 12, 2024

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. Widera and Smith have no relationships to disclose.

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IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

JUNE 13, 2024

I feel like I recognize it when I see it, but I struggle to give a clear definition or provide effective ways to address it. Widera and Smith have no relationships to disclose. Guest Eduardo Bruera has no relationships to disclose. And it’s something that we see a lot with many of the medications we use in cancer.

Illness 133

Illness Patient-Centered IT Patients 133

GeriPal

AUGUST 17, 2023

Alex: And we’re delighted to welcome Nate Chin, who is associate professor at the University of Wisconsin, where he is medical director of their Alzheimer’s Disease research center and runs a large study in Wisconsin called the RAP Study studying Alzheimer’s Disease. Welcome back to GeriPal podcast, Sharon. Eric: Yeah.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

OCTOBER 3, 2024

I was on a retreat with Guy Micco , who’s been on this podcast several times, and he was teaching a class on death while I was in medical school. What is it about the images of the dying that helps teach medical students? And dying is too big, too profound for any one model, including the medical model. Wendy, I have.

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IT Patient-Centered Patients Relationship 122

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. So thought it related to our theme of disruptive events about different ways in which you may experience an early demise.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

OCTOBER 27, 2022

And really providing these estimates of how long a person has to live affects a lot of the decisions we have to make clinically. That’s a difficult decision to make, and providing these estimates can help clinicians and patients with that type of shared decision-making. ” I love The Onion.

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IT Clinic Screening Patients 95

GeriPal

FEBRUARY 2, 2024

Panelists Kate Courtright and Scott Halpern have no relationships to disclose. So if you have say two similar patients who go to the ICU with COPD, both are an event, one lives for 27 days and dies in the ICU, the other one gets a palliative care consult and dies four days from hospital admission. and consulting for Papa Health.

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Consulting Hospital Patient-Centered IT 120

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. So in some ways, it was an iatrogenic event. There was also a second event in that the pressures chosen weren’t the ideal ones. And it’s not the same, but it does provide information. We can make this better.

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Patients IT Patient-Centered Hospital 98

GeriPal

SEPTEMBER 19, 2024

So at our cancer center, we have physicians, advanced practice providers. Jennifer 20:48 We don’t, you know, our palliative care team here in the outpatient setting is only physicians and advanced practice providers. So, for example, the intervention visits had to be delivered by a physician or advanced practice provider.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. What do we do to very concretely provide heat shelters and cool shelters? Ruth: Right. And then access to those.

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Healthcare IT Education Hospital 129