FDA Law Blog

MARCH 16, 2023

The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.” The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g.,

Healthcare Professional 40

Healthcare Professional Specialization Transportation Diagnosis 40

Annals of Family Medicine

NOVEMBER 20, 2024

Primary care practices are frequently the first and sometimes the only healthcare setting where patients with OUD seek care, and practices need support with resources and training in how to best treat this growing population. Objective: To understand perspectives and needs of primary care clinical staff in addressing the OUD epidemic.

Primary Care 130

Primary Care Transportation Family Physician Education 130

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. A greater social risk burden was linked to increased odds of unplanned healthcare utilization (severe vs none: OR, 3.5 [1.2-10.2])

Healthcare 52

Healthcare Transportation IT Insurance 52

The Clinical Problem Solvers

MARCH 4, 2024

42:00 Abolitionist reimaginings of Health 55:05 Democratizing Narrative Medicine 1:03:05 Closing Remarks and Clinical Pearls Speaker biographies (Abbreviated) Zahra Khan is an educator and editor whose work emerges at the intersection of narrative, healing and disability justice, and liberation pedagogy.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

JUNE 12, 2025

Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. I’m sort of seeing them in clinic for consideration of palliative radiation, they have a lot going on. Evie, welcome to GeriPal. Evie 00:41 Thank you. Do you have the song request for Alex?

Patient-Centered 102

Patient-Centered Referral Patients IT 102

GeriPal

FEBRUARY 15, 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. Eric: Oh, no.

Community 114

Community Transportation IT PCP 114

GeriPal

JANUARY 16, 2025

I, for example, had one patient, I remember during my fellowship, I was in geriatrics clinic and had a very well read patient who came in and was reading a New York Times article, I think in the well section at one point. Alex 16:45 That really rings true with my clinical experience. So there’s no healthcare surrogate.

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. AMA PRA Category 1 credit(s) ™. Who do we have with us today? Katie, welcome back to GeriPal.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

JANUARY 30, 2025

Find out on this weeks podcast where we invite Joseph Greer, Simone Rinaldi, and Vicki Jackson to talk about their recent JAMA article on Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer – A Multisite Randomized Clinical Trial. So no differences between the modalities.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. So we’re trying to help replace the transportation option. Eric: Let’s say I have a panel of older adults that I’m seeing, or a palliative care outpatient clinic. Is this our role?

IT 102

IT Family Families Diagnosis 102

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Is my sore throat contagious?

ER 52

ER Telehealth Primary Care Doctor Appointment 52

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

OCTOBER 17, 2024

He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge. Alex 04:07 A heart failure clinic playing in the background. Alex 00:12 We have a guest host who has requested this episode, Matt Shuster, who’s a geriatrician and palliative care doc. He’s in Boston.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

APRIL 4, 2024

In case you miss the introductions at the start of the podcast, Bernie and Laurie are married, and offer wonderful reminiscence of their clinical practice over the last several decades. Eric: Initially it started with living wills back in the early-1970s development of durable-powered attorneys for healthcare. Alex: Bernie.

Family 112

Family Families Patient-Centered IT 112

GeriPal

DECEMBER 5, 2024

It’s that mixture of intimacy and vulnerability, of shared clinical experiences, that fosters a sense of belonging. We definitely draw on the sciences, on biomedical science, on clinical trials, on pharmaceutical design and all sorts of things like that. There’s obviously a lot of flaws in the healthcare system.

IT 107

IT Community Patients Family 107

GeriPal

SEPTEMBER 29, 2022

Hypnosis: uses and how to get training via the American Society of Clinical Hypnosis. I’ll have to share with you my clinical experience and my reading of the literature. Remember, there’s an active transport metabolism for gabapentin, if we’re nerding out here. Lidocaine: worth the hype?

Management 101

Management IT Patients Family 101

GeriPal

JUNE 5, 2025

So it’s, you know, nursing homes are part of the healthcare sector, but they’re also part of the social care sector in the same building. So they were a lot of preoccupied with other tasks, but clinical gestalt. If you have 100 beds in the building, 20 of them today might be rehabbed people who are there.

Nurse Practitioner 78

Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. Rosanne: I certainly do.

IT 105

IT Healthcare Professional Healthcare Transportation 105

GeriPal

JULY 6, 2023

This includes transportation, driver’s license, parks, volunteerism, housing, and of course health and human services. Eric: Which is, so let’s say I am a provider, a healthcare provider taking, let’s say a nurse practitioner working in an older, a clinic that’s mainly caring for older adults.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 21, 2023

Eric: And looking back at that time, what do you think the healthcare system could have done to help with that? We have all of these models that are out there that have proven benefits for patients, for caregivers, and some of them for healthcare systems as far as saving money for, let’s say, Medicare. ” Diane: Fantastic.

Patient-Centered 125

Patient-Centered IT Families Family 125

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115