FDA Law

JANUARY 30, 2025

In its new guidances, FDA advises that sponsors should consult with the Agency regarding confirmatory trial design and conduct as early as possible with enough time to allow the trial to be underway at the time of approval. Take steps to facilitate high retention including by incorporating patient perspectives into the design of such trials.

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IT Clinic Provider Patients 105

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This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.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. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Patient-Centered Clinic Patients Provider 49

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

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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Manufacturing Engineering Clinic Patients 45

FDA Law

JANUARY 12, 2025

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

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FDA Law

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act.

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Clinic Provider IT Patients 52

GeriPal

DECEMBER 2, 2022

He wrote a book titled “ Psychiatric consultation in long term care ” that has a strengths based approach to staging dementia (how cool is that). She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. And the person with dementia, the patient, said yes.

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Community IT Individual Patient-Centered 101

GeriPal

MAY 5, 2022

And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. It’s amazing.

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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. and consulting for Papa Health. And, of course, this is what families of patients undergoing palliative care go through.

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Consulting Hospital Patient-Centered IT 120

Dr. Michael Bazel

JUNE 16, 2025

With additional offices in Panorama City and Bell, his practice offers comprehensive hormone testing and treatment in Valley Village and beyond to help patients regain balance and well-being. Schedule a consultation with Dr. Bazel today to explore whether your symptoms are caused by stress, a hormone imbalance, or both.

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IT Physicals Management Diagnosis 130

StorytellERdoc

FEBRUARY 8, 2019

Recently, due to the stress that several of my dearest friends have been experiencing in caring for their elderly parents, I am even more appreciative and respectful of my privilege in caring for elderly patients who have attentive and loving adult children who accompany them to our ER. We sat the back up for her to be more comfortable.

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ER Family Families Transportation 100

Today's Hospitalist

JUNE 7, 2025

Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. That’s according to two internists who work closely with hospitalized patients who take GLP-1s. These medications are truly life-changing for many patients.”

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Hospital Management Diabetes Patients 66

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. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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DO Family Medicine Families Family 40

FDA Law

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. establish and maintain adverse event files.” [9] establish and maintain adverse event files.” [9]

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Manufacturing Provider Physicals Electronics 64

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. It was eyeopening to see patients in their own home. And so that really triggered my interest.

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GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

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Patient-Centered Hospital Patients IT 132

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

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. The patient case. So in some ways, it was an iatrogenic event. Alex 03:33 Yeah.

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Patients IT Patient-Centered Hospital 98

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? 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 52

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.

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Patient-Centered Complication Patients IT 101

GeriPal

DECEMBER 5, 2024

We talked with Thor Ringler, who helped found the My Life My Story Project at the VA and beyond, and Heather Coats about the evidence base for capturing patient stories. It was like kind of a co op with this common space that different groups could rent for events and meetings and things like that. And we had these amazing stories.

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IT Community Patients Families 107

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. Kate 06:44 Patients were willing to complete advanced directive and picked the middle one. What is sludge? Where was it?

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Patient-Centered Hospital IT Illness 116

GeriPal

OCTOBER 5, 2023

I love this article as it specifically discusses what’s wrong with “ need ” statements and how we can shift our communication and thinking to create space for deliberation about patients’ priorities and the best course of action. Now doctors are unwilling to understand patients’ values and make recommendations, taking the science to it.

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Illness IT Patient-Centered Families 136

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. Healthcare staff were afraid of patients with HIV because there wasn’t clarity on how it was transmitted. Welcome to the GeriPal podcast, Michele.

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Family Families IT Community 132

GeriPal

MARCH 13, 2025

Yes, it means to cloak, but theres more Whole-person-care Total pain Healing as a process distinct from the deterioration of the body Sympomatologists The patient and family as the unit of care Our guests referenced many articles on this podcast, linked above and below. We each had an average between 23 and 25 patients each.

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IT Patient-Centered Families Family 104

FDA Law

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

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Clinic Provider Individual IT 59

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

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Manufacturing Consulting Healthcare Professional IT 40

GeriPal

MARCH 6, 2025

And this is really traumatic event for his street family and the street community that he knew. And I wonder if that is key in patients, people who are experiencing homelessness as well. Eric 40:08 Okay, right after this podcast, I gotta go back to the inpatient consult service so you can see I’m focused on this issue.

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Healthcare IT Community Illness 100

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

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Patient-Centered IT Patients Hospital 119

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Why do this? Widera and Smith have no relationships to disclose.

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Families Family Patient-Centered IT 106

GeriPal

AUGUST 1, 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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IT Diabetes Chronic Disease Patient-Centered 116

GeriPal

NOVEMBER 3, 2022

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. So people are less able to have the language when the loss event actually happens. Turns out, it’s maybe not. And we don’t talk about it as much.

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Healthcare Professional Healthcare IT Relationship 102

FDA Law

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. Perhaps anticipating a less than favorable outcome, DOJ counsel several times asked to be allowed to submit a brief on the question of the remedy in the event of an adverse ruling.

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Patient-Centered Consulting Government Clinic 102

PEMBlog

MAY 9, 2024

Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. If you have two or more febrile seizures, you have a 50% chance of subsequent events. You should develop a specific plan for each patient with each patient. A pediatric neurologist.

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Illness Vaccination Families Family 59