FDA Law Blog

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). Additionally, the Guidance states that sponsors should provide study plans for FDA review. What to measure, when, and for how long?

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. And there’s so much work on, you know, you’ve got to take these medicines, you got to prevent this treat, that there isn’t that same sort of clinical momentum towards deprescribing. Ethical and practical.

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Specialization IT Patient-Centered Medical 119

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. The contemplated activities here would not in any event affect the “quality” of the compounded formulation.

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GeriPal

OCTOBER 13, 2022

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). difficile infections.

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PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting.

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Diagnosis Management IT Patient-Centered 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? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And he is also a clinical audiologist, which is going to be key for this podcast. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

GeriPal

JULY 27, 2023

Alex: And we have Cathy Alessi, who is a geriatrician, Director of the Geriatrics Research Education and Clinical Care Center at the VA, greater Los Angeles and Professor of Medicine at UCLA. Sleep is a focus of your academic and clinical career. ” That actually happens a lot in the sleep clinic. Cathy: Thank you.

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Illness IT Clinic Medical 85

GeriPal

DECEMBER 2, 2022

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? We need to learn from them that they have moved on, so how do we not dwell in the past negative events? It has to be seen as valued to clinical outcomes.

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Community IT Individual Patient-Centered 101

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Remember that more deeply understanding your patients can provide meaning! The Clinical Problem Solvers Podcast. 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. I think, as providers, we don’t get to see that.

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FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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Manufacturing Provider Physicals Electronics 64

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. Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. Eric 04:19 Yeah.

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Patient-Centered IT Individual Screening 67

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. Physical therapy had walked with him that day and noted improvement compared to previous walks, suggesting that he should be discharged to a skilled nursing facility for rehabilitation on discharge.

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GeriPal

JULY 11, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Patient-Centered IT Patients Clinic 109

GeriPal

FEBRUARY 8, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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Clinic Provider Individual IT 59

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. And that led to many specialists doing work and advancing their fields within their professional societies, providing guidance and so on for older adults. difficile infections.

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Complication Patient-Centered IT Patients 52

FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Terragene S.A.,

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Manufacturing Clinic Medical IT 59

GeriPal

OCTOBER 17, 2024

He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge. Alex 04:07 A heart failure clinic playing in the background. If they’re frail, if they’re falling, if they have cognitive impairment, they’re at higher risk of adverse drug events. He’s in Boston.

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Primary Care Patient-Centered IT Patients 113

GeriPal

MAY 22, 2025

A music therapist would use music deliberately to achieve a rehabilitation goal, just like a physical therapist or an occupational therapist. He’s bringing in, like, a physical record player, but now also in hospice units as well, they’re bringing out music players with headphones. I am not a board certified. Oh, my gosh.

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IT Patient-Centered Patients Board-Certified 97

GeriPal

JULY 28, 2022

And as a resident, I just was drawn, similar to many oncology clinicians and fellows, to just be traumatic and difficult experience of patients with blood cancers during prolonged and intense hospitalizations, where they experience a lot of physical symptoms, emotional trauma related to the diagnoses. Improved quality of life.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

OCTOBER 12, 2023

Gretchen: Yeah, I think probably the underlying story here is that I’m really good at doing negative randomized clinical trials, but there is a good thing about doing a big clinical trial, which is that you get tons of data even if you don’t end up with the result that you want. We hope you enjoy this episode.

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IT Families Family Patient-Centered 128

GeriPal

OCTOBER 27, 2022

As Alex Lee says on our podcast today, all prognostic models will be wrong (in some circumstances and for some patients); our job is to make prognostic models that are clinically useful. As Sei Lee notes, the argument for developing prognostic models has won the day, and we increasingly use prognostic scores in clinical decision making.

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IT Clinic Screening Patients 95

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. I backed into that role. That’s true.

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IT Healthcare Healthcare Professional Patient-Centered 111

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty.

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Patient-Centered Patients IT Illness 96

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. And that grew into a group of volunteers coming back and at least providing support groups, giving those men a place where they could talk at least. There are clinics.

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Families Family IT Community 132

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. How should I define cachexia and anorexia when I’m talking to fellow students or thinking about it in my own clinical practice? But what I tell them is, keep yourself physically active.

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Illness Patient-Centered Patients IT 133

GeriPal

OCTOBER 5, 2023

Sunita: Honestly, I’d be happy to provide the vocals. We need to strike it from our vocabulary and leave sort of a gap in the clinical vernacular about how we talk about life-sustaining treatment. It’s such a physical act, showing just how strong doctor’s moral resolve is to save a life. laughter] Alex: Great.

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Illness IT Patient-Centered Families 136

GeriPal

APRIL 3, 2025

So if you haven’t been to this event, there is a literature review where we. It always has clinical relevance to practice today. I’m gonna be very brief on the other two because of that warning, but Eric talked me into, in the first year in doing an article on the impact of rudeness on clinical care that.

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IT Hospital Screening Patients 64

GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Tsai-Chin 01:02 Thank you.

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Illness Hospital IT Patient-Centered 73

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

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.

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Patient-Centered IT Patients Hospital 119

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.

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Healthcare IT Education Community 129

GeriPal

NOVEMBER 3, 2022

So take a listen and check out some of these resources for healthcare provider loss, grief, and wellness: Loss and Grief: Personal Stories of Doctors and Other Healthcare Professionals. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Craig: Thanks so much, Alex and Eric.

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Healthcare Professional Healthcare IT Relationship 102

GeriPal

JULY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Families 106

Families Family Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. Folks who were first homeless after 50, there was an event, and usually those events could be described in one of four categories.

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