FDA Law Blog

JUNE 3, 2025

We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice. tablets to patients over the course of many months.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 59

GeriPal

JULY 19, 2024

Joseph Gaugler is the Director of the Center for Healthy Aging and Innovation at the University of Minnesota, director of the BOLD Public Health Center of Excellence on Dementia Caregiving, and Editor-in-Chief of the Gerontologist. Should it? If so, how do we screen and who do we screen? Who should get it if anyone? Soo 00:32 Thanks.

Screening 120

Screening Primary Care Patient-Centered IT 120

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA. The following is a summary report of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

GeriPal

JUNE 20, 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 121

IT Patient-Centered Patients Clinic 121

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.

IT 125

IT Hospital Patient-Centered Individual 125

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. What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? .

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101

The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R.

Community 52

Community Patient-Centered Relationship Education 52

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

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. Emily, welcome to GeriPal.

Patient-Centered 103

Patient-Centered Referral Patients IT 103

GeriPal

JUNE 27, 2024

How, though, do we navigate anxiety and help our patients who may end up in the anxiety spiral that becomes so hard to get out of? Summary Transcript Summary “Anxiety is a lot like a toddler. It never stops talking, tells you you’re wrong about everything, and wakes you up at 3 a.m.”

Illness 130

Illness IT Diagnosis Patient-Centered 130

FDA Law Blog

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. Proposed 2022 CDC Practice Guideline, 7,839. By Larry K.

Patient-Centered 75

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.

Patient-Centered 91

Patient-Centered Community IT Medical 91

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. Show me your scars.” Scars, really? I’ve been there. You probably have too. Michelle 01:22 Thanks for having us today.

Screening 121

Screening IT Families Family 121

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 137

Illness Patient-Centered Screening Clinic 137

GeriPal

FEBRUARY 29, 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 127

IT Patient-Centered Illness Education 127

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The group discussed policy shifts and potential implications for graduate medical education and health equity. The following is a summary of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law Blog

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.

Provider 108

Provider Patient-Centered Clinic Patients 108

GeriPal

OCTOBER 19, 2023

Caveat as well that RCTs should not be placed on pedestal as the only answer- often patients enrolled in RCTs do not represent real world patients – observational studies do. For a trial to have value, it should not exclude patients over age 80, or those with dementia, or patients residing in nursing homes.

Patient-Centered 127

Patient-Centered IT Patients Illness 127

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. The hospital refused without a court order, and the case eventually made its way to the Supreme Court.

Families 113

Families Family Patient-Centered IT 113

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. 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. But my medical training kicked in.

Patients 74

Patients Clinic Patient-Centered Illness 74

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R., RR-3):1–95.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

FEBRUARY 6, 2025

We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. To start things off, Nate’s a returning guest. Great to be back.

Primary Care 97

Primary Care Diagnosis Screening IT 97

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great. All right.

IT 100

IT Community Patient-Centered Medical 100

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). Eric: And we have L.J Welcome to the GeriPal podcast. LJ: Thank you so much for having me. Sarah: It is.

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

MARCH 28, 2024

And we have Kate Courtright, who’s at University of Pennsylvania, the PAIR Center. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? We are at AAHPA…uh.AAHPM… Alex: Was it a long night last night? laughter] Eric: 2:30 AM.

Consulting 116

Consulting Patient-Centered Patients IT 116

GeriPal

JUNE 13, 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.

Illness 134

Illness Patient-Centered Patients IT 134

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.”

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: Thank you guys.

Patient-Centered 112

Patient-Centered Patients IT Healthcare 112

GeriPal

SEPTEMBER 12, 2024

She’s a geriatrician and palliative care doc and is associate chair for professional development in the department of Psychosocial Oncology and Palliative Care at the Dana Farber Cancer Institute and Harvard Medical School. Well-being committees are popping up at every level of an organization. Jane, welcome to the GeriPal podcast.

IT 112

IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR.

Patient-Centered 79

Patient-Centered IT Patients Illness 79

GeriPal

AUGUST 24, 2023

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. We talk with Harvey about how he defines “dignity” and how we can understand what it means to our patients. Scientific American Letter to the Editor: Response to Downar et al.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. Mariah, welcome to the GeriPal Podcast. Kate 00:40 Great to be here.

IT 67

IT Patient-Centered Individual Screening 67

GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

IT 89

IT Patient-Centered Patients Medical 89

GeriPal

JULY 13, 2023

On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Alex: And Ruth Engelberg, who is an esteemed palliative care and palliative care researcher also at the University of Washington and can be a palliative care center of excellence.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component).

Primary Care 80

Primary Care IT Clinic Patient-Centered 80

GeriPal

DECEMBER 1, 2023

In particular we spend a good deal of time talking about what this means for asymptomatic patients who may have an abnormal biomarker, which by the proposed new definition would mean they would now have Alzheimer’s disease. Alex: We have an all-star cast. Heather, welcome to the GeriPal podcast. Jason, welcome back to GeriPal.

IT 117

IT Clinic Illness Hypertension 117