FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. By John W.M. Combination products might be part drug, part device, or part software or hardware.

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Manufacturing Patient-Centered Provider Telehealth 59

GeriPal

JANUARY 23, 2025

Today, we explore four fascinating studies highlighting innovative approaches to reducing medication use and improving patient outcomes. Patients received brochures detailing the risks of gabapentinoids, nonpharmacologic alternatives, and a proposed deprescribing regimen (see here for the brochure ). in the usual care group.

Specialization 119

Specialization IT Patient-Centered Medical 119

FDA Law

SEPTEMBER 23, 2022

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

Medical 52

Medical IT Patient-Centered Clinic 52

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

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Board-Certified Board-Certified Physicians Community Government 40

FDA Law

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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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Clinic Relationship Provider IT 64

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. &

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 52

GeriPal

OCTOBER 13, 2022

When I’m on service these days there is inevitably a moment when a resident says “Patient so-and-so is on X” – and I have absolutely no idea what X is. Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

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Complication Patient-Centered IT Patients 97

FDA Law

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. stroke).

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Patient-Centered Clinic Patients Provider 49

FDA Law

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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Manufacturing Hospital Healthcare Medical 81

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction.

Management 52

Management Patient-Centered Appointment Patients 52

GeriPal

DECEMBER 2, 2022

She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. You wrote about how when it comes to talking about patients with dementia, they’re rarely portrayed as resilient. And the person with dementia, the patient, said yes. How do we move on?

Community 101

Community IT Individual Patient-Centered 101

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. Welcome to the GeriPal podcast, Brienne. Brienne: Thank you for having me.

Illness 85

Illness IT Clinic Medical 85

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

FDA Law

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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Provider Patient-Centered Clinic Patients 108

The Clinical Problem Solvers

DECEMBER 20, 2021

[link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. CDC Clinical Practice Guideline, 10. By Larry K. 7,838 (Feb.

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Patient-Centered Clinical Practice Patients Individual 75

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Early data on efficacy in patients with anxiety and demoralization are promising. She’s also a leader in the Cancer Prevention and Control Center at the University of Colorado there at the Cancer Center.

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Patient-Centered Community IT Medical 91

GeriPal

JULY 11, 2024

It’s a jampacked 50 minutes, filled with pearls on taking care of patients with liver disease. Kirsten 04:16 So, in emergency medicine, obviously, we are interacting and caring for these both exciting and interesting, but also very complex and humbling patients to care for in the ED setting. AMA PRA Category 1 credit(s) ™.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

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. Going into patient’s homes was eye opening. And yet, after assisting the older adult to their feet, the EMS providers would leave.

Community 115

Community Transportation IT PCP 115

GeriPal

NOVEMBER 7, 2024

If the purpose of initiating dialysis is improving function – our complex, frail, older patients are likely to be disappointed. Are we seeing people like more older adults, more nursing home patients starting dialysis, and even at a higher gfr? So I wonder if I could turn to either of our nephrologists.

Management 116

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.

Patient-Centered 67

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. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility. Dear listeners, if you have a podcast idea, feel free to reach out to us.

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Patient-Centered Hospital Patients IT 132

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. Rasheeda, welcome to GeriPal.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

MAY 22, 2025

Jenny Chen is a palliative care fellow at Yale who regularly sings for her seriously ill patients. Jenny reached out to us because she plays music regularly for her patients, and she said, you should do a podcast about music. And I performed for many palliative patients, and that’s when I started to understand.

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IT Patient-Centered Patients Board-Certified 97

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. When I see a patient? He’s in Boston.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

MAY 25, 2023

Others cited the call from communities to meet them where they are – be they senior centers, Black-owned businesses, or churches (we have a podcast planned in the fall with Fayron Epps and Karen Moss on the church setting). So am I measuring it for that specific clinic level quality metric or am I measuring it for my research study?

Community 96

Community IT Patient-Centered Primary Care 96

Maine Academy of Family Physicians

OCTOBER 22, 2023

Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. I also spent one day at the Maine Family Planning clinic in Augusta, shadowing the head clinician, Lindsey Piper, NP. At the Family Medicine office, I observed the close relationships fostered between Dr. Der Simonian and her patients.

Medical Student 40

Medical Student Family Medicine DO Patient-Centered 40

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. Clinicians were randomized to 4 groups: Usual care Prognosis nudge – EHR prompt asking, do you think your patient will be alive in 6 months?

Patient-Centered 117

Patient-Centered Hospital IT Illness 117

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. He’s chair of the department of Palliative Rehabilitation and Integrative Medicine at MD Anderson Cancer center. But the patient would say, well, but it still hurts, though. Come down here.

Illness 133

Illness Patient-Centered Patients IT 133

GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. We hope you enjoy this episode. And that’s how we connected.

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IT Families Family Patient-Centered 128

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. Eric: And what a research agenda that you’ve done, including one of the most seminal papers that we have in palliative care in lung cancer patients.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

JANUARY 26, 2023

Ramona: Well, I’ve always been interested in health equity, always been interested in looking at disparities, and the disparities that I have looked at most often have been for patients at the end of their lives. The trainee said to me something like, “But I haven’t seen any geriatric patients yet.” Eric: Yes.

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IT Patient-Centered Healthcare Patients 92

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. If you were just. If you could make it, if we.

IT 111

IT Healthcare Healthcare Professional Patient-Centered 111

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.

IT 137

IT Families Family Physicals 137

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.

Patient-Centered 96

Patient-Centered Patients IT Illness 96