FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. After all, FDA has access to all of the data submitted in applications and all of the review information related to those data. By Adrienne R.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

The Clinical Problem Solvers

MARCH 14, 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. Dr. Kevin M.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

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

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

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. So that’s one, this patient-centered geriatric assessment and management approach.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. And I think that we’re at this kind of crossroads right now in dysphagia, and dysphagia management where our patients are suffering. We revisit it, and make things better for our patients.

Hospital 124

Hospital IT Patient-Centered Individual 124

GeriPal

APRIL 27, 2023

Attendee 9: Early integration of palliative care in medical education. 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 11: I am hopeful that the model of care that we deliver is what our patients and their caregivers want, need and deserve.

Specialization 93

Specialization Illness Healthcare Patient-Centered 93

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.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law Blog

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. However, the 2014 Guidance cannot be ignored entirely.

Clinic 64

Clinic Relationship Provider IT 64

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. What are the risks and rewards of new classes of medications? When I’m on nursing home call, the most common page I receive is for a blood sugar value.

Diabetes 73

Diabetes Management Patient-Centered Families 73

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

Permanente Medicine

JUNE 3, 2025

They candidly discuss the unique challenges and opportunities health care organizations face in meeting patient expectations. Assistant Regional Medical Director, Care Experience Southern California Permanente Medical Group Podcast transcript Transcript is autogenerated. Guest Wadie L. Marcos, D.O. I find them very stimulating.

IT 52

IT Patient-Centered Patients Medical 52

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. Anish 01:02 Well, I speak, you know, from a physician lens of some of the patients that I get referred, and by the time there’s. This is not a good option.

Patient-Centered 102

Patient-Centered Referral Patients IT 102

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? laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eloise, welcome to the GeriPal podcast. Eloise 00:59 Thank you so much.

Medical 98

Medical IT Patient-Centered Healthcare 98

Plum Health

OCTOBER 11, 2024

Have you ever found yourself in need of medical attention but overwhelmed by the myriad of clinics and healthcare options out there? 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.

Clinic 52

Clinic Primary Care Doctor Primary Care Chronic Condition 52

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.

Diagnosis 130

Diagnosis Management Illness Diagnose 130

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.

Consulting 120

Consulting Hospital Patient-Centered IT 120

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.

Telehealth 105

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. Eric: And Alex, who do we have with us today? David: Thank you.

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

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. 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. Claire: And it was.

Insurance 52

Insurance IT Board-Certified Medical 52

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.

Clinic 52

Clinic Chronic Disease Management Primary Care Medical 52

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?” We’re excited to welcome a full slate of guests today.

Family 97

Family Families Patient-Centered IT 97

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. I was always critical care bound since medical school.

Consulting 99

Consulting Patient-Centered Diagnosis Referral 99

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.

IT 99

IT Patient-Centered Patients Healthcare 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. ABIM MOC credit will be offered to subscribers in November, 2024.

Illness 136

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

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. Kate: These are very sick patients. Kate: Sure.

Consulting 115

Consulting Patient-Centered Patients IT 115

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. They were stunned by the number of calls for lift assistance for older adults who had fallen.

Community 114

Community Transportation IT PCP 114

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

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. The collaboration is actually the center. Michelle 01:22 Thanks for having us today. DorAnne, welcome to GeriPal.

Screening 119

Screening IT Families Family 119

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. He’s a linguistic and medical anthropologist at the University of Pennsylvania. Justin: Hello.

IT 128

IT Families Family Patient-Centered 128

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? But my medical training kicked in. What is making this hard for me? Janet 00:26 Thank you so much.

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Patients Clinic Patient-Centered Illness 72

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

Illness 101

Illness IT Patient-Centered Patients 101

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. And it’s always centered on a need for a particular life-sustaining treatment. This is Eric Widera.

Illness 136

Illness IT Patient-Centered Families 136