FDA Law Blog

MAY 29, 2025

According to the global consulting group ICF, the pilot used an ICF-developed Computerized Labeling Assessment Tool (CLAT) to read drug labels and pinpoint specific items for review, with the goal of improving the effectiveness of the drug labeling review. We have all seen AI failures online, some amusing (e.g.,

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

The Medical Futurist

MAY 18, 2025

Robotic nurses dressing mannequins and bed-bathing patients Delicate movement, like gently handling an elderly patient is traditionally the most challenging task to robots, who are much faster developing in intellectual tasks than matching humans in fine-motor skills. Since then, the concept has become a reality.

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Healthcare Hospital Medical Patient-Centered 64

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

Families 101

Families Family Hospital Patient-Centered 101

The Clinical Problem Solvers

APRIL 24, 2025

Her mission — preparing the next generation of diverse physician leaders in pediatric healthcare and mental health and creating partnerships between communities and academic centers — will be critical for eliminating disparities among minority populations. A Culturally Informed Approach to Supporting Suicidal Minoritized Patients.

Mental Health 52

Mental Health Community Hospital Appointment 52

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

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Hospital Patient-Centered IT Nurse Practitioner 100

FDA Law Blog

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This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.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 The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.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

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. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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Clinic Relationship Provider IT 64

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

APRIL 27, 2023

The company has expanded its palliative care services through partnerships with hospitals and other managed care providers, according to AccentCare CEO Stephan Rodgers. Attendee 11: I am hopeful that the model of care that we deliver is what our patients and their caregivers want, need and deserve. Attendee 18: The science.

Specialization 93

Specialization Illness Healthcare Patient-Centered 93

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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Manufacturing Engineering Clinic Provider 59

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Should we use Ozempic (if we can find it) in patients with serious illness, which often results in undesirable and profound weight loss? How high is too high?

Diabetes 73

Diabetes Management Patient-Centered Families 73

GeriPal

JUNE 12, 2025

Summary Transcript CME Summary If you’re anything like me, you might find the process of what happens to patients when they visit a radiation oncologist somewhat mysterious. Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. Evie, welcome to GeriPal.

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Patient-Centered Referral Patients IT 102

Permanente Medicine

JUNE 3, 2025

They candidly discuss the unique challenges and opportunities health care organizations face in meeting patient expectations. I just listened to the one on national cancer care that we’re doing, which was very informative and pretty impressive. For me specifically, it’s how do we make a patient feel.

IT 52

IT Patient-Centered Patients Medical 52

Plum Health

OCTOBER 11, 2024

This guide will help you understand the different types of clinics and services they offer, so you can make an informed decision about where to seek medical care. They also provide immunizations and lifestyle advice tailored to your specific needs. Do you prefer a full-service medical center or a walk-in clinic?

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Clinic Primary Care Doctor Primary Care Chronic Condition 52

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 PAIR stands for the Palliative and Advanced Illness Research Center.

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Consulting Hospital Patient-Centered IT 120

Rao Doctor

APRIL 3, 2025

Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. The choice of method depends on the patient’s age, condition, and preference, with rectal measurements often being the most precise for infants and young children.

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Diagnosis Management Illness Diagnose 130

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. Consultations versus telehealth. But watch out! Alex 01:06 Yeah, go in person.

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Telehealth Patient-Centered IT Patients 105

GeriPal

JANUARY 25, 2024

He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. With their regular providers? Lyndsay: Yes.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 16, 2025

So I think the first reason that we saw and felt the opportunity was ripe for updating was that some of us had come across some anecdotal examples of patients expressing some offense to that terminology. And I was asking this patient about if he had filled out an advanced directive. Is the patient in your descriptor?

Patient-Centered 109

Patient-Centered IT Patients Healthcare 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.

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Community Transportation IT PCP 114

GeriPal

JUNE 9, 2022

The National Palliative Care Research Center (NPCRC)and Palliative Care Research Cooperative (PCRC)were founded in part to meet this need. She’s also a member of the PAIR Center, which stands for Palliative Advanced Illness Research Center. And I practiced both on the palliative care consult team and in the ICU.

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Consulting Patient-Centered Diagnosis IT 99

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. AMA PRA Category 1 credit(s) ™. Katie, welcome back to GeriPal.

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Illness Patient-Centered Screening Clinic 136

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.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

FEBRUARY 23, 2023

Summary Transcript Summary You know when you walk out of a patient’s room and have that sense, “This isn’t going to go well.” The patient is sick and getting sicker, and refuses to let you talk with family or other members of her inner circle. Should you stop at “no?” Lynn: I do. Alex, can you play Send the Sun, by Nikki Lane?

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Families Family Patient-Centered IT 97

GeriPal

JUNE 15, 2023

Alex: And we have Matt DeCamp, who’s joining from the University of Colorado, where he is a primary care internist and bioethicist at the Center for Bioethics and Humanities. Charlotta: Yeah, I think it will be in reducing the need to spend so many hours on documentation and looking through the EHR for information. Eric: Yeah.

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IT Patient-Centered Patients Healthcare 99

GeriPal

MARCH 28, 2024

And we have Kate Courtright, who’s at University of Pennsylvania, the PAIR Center. We all, when bombarded with information have to take certain elements of a decision and focus on those; and in the ICU, you can imagine, we’re bombarded with information a lot. They study palliative care. Eric: Nudge it.

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Consulting Patient-Centered IT Patients 115

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. Eloise, welcome to the GeriPal podcast.

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Medical IT Patient-Centered Healthcare 98

GeriPal

APRIL 4, 2024

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024.

Families 112

Families Family Patient-Centered IT 112

Plum Health

OCTOBER 16, 2024

Whether you’re in Detroit , Corunna , Lansing , Royal Oak , or Van Buren , this clinic is offering comprehensive care that puts patient well-being first. From managing chronic diseases like diabetes and hypertension to preventive care and health screenings, the clinic is known for providing patient-centered care.

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Clinic Chronic Disease Management Primary Care Medical 52

Physician's Weekly

JUNE 19, 2025

His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting. This is the kind of information we all need, all deserve. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. It was denied.’

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

Illness 107

Illness IT Patient-Centered Patients 107

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

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. P AI R stands for Palliative and Advanced Illness Research Center. What is sludge? Both the prognosis and comfort care nudge.

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

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. Sunita: Honestly, I’d be happy to provide the vocals. This is Eric Widera. Alex: This is Alex Smith.

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

FEBRUARY 27, 2025

We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Who follows the patient once the cancer goes into remission? I see this in the hospital when I’m doing addiction medicine consults.

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Patients Clinic Patient-Centered Illness 72