FDA Law

APRIL 23, 2023

Notably, the Draft Guidance states that it is not intended to address other types of external controls, such as using summary-level estimates instead of patient-level data, nor does it discuss the use of external control data to supplement a control arm in a traditional randomized controlled clinical trial.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

JUNE 27, 2024

“A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice” and “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 25, 2024

David: Similarly informed by my clinical experience, really, actually, beginning in residency when I took care of a lot of sick folks in the hospital, particularly those with cancer and heart and lung diseases like these. However, its main predictors are age, comorbidity, and healthcare utilization. Eric: How about you, David?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

JUNE 9, 2022

Clinical growth of geriatrics programs has lagged academic research, despite the rapid aging of the population. . In contrast to geriatrics, the evidence base for palliative care lagged clinical growth, in part because palliative care has no centralized “home” at the National Institutes of Health. Particularly in the inpatient setting?

Consulting 99

Consulting Patient-Centered Diagnosis IT 99

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. It did not change the frequency of palliative care consultation, the timing of such, ICU mortality, or six-month mortality.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

FEBRUARY 15, 2024

So what we found is up to 30% of people would call 911 again for a fall, and of those calls, some people became very high-utilizers and so they would call 911 over and over again. I think once someone becomes kind of a high-utilizer, it’s a slippery slope. All of these are factors that are on the individual level.

Community 114

Community Transportation IT PCP 114

PEMBlog

JUNE 2, 2025

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Hypertensive emergency is a clinical diagnosis characterized by a sudden and severe elevation in blood pressure accompanied by signs of acute end-organ dysfunction. Look for the underlying cause renal disease leads the list in kids.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Meaning that an individual must inherit two copies of the mutation, so one from each of his or her parents, to be affected. And not all IEMs are included on NBS, NBS can miss individuals with IEMs.

Consulting 59

Consulting Individual Families Family 59

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. Ann Henshaw is an occupational therapist who works clinically at Georgetown and teaches at GW. Alex: Today we are delighted to welcome Ann Henshaw who brought this podcast idea to us.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

FDA Law

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

JUNE 5, 2025

So, how can we improve palliative care for individuals in nursing homes? And so we do have consultants who come in the building. And usually it’s simply for a consultation. Eric 17:06 Think like almost 50% of nursing home decedents utilize hospice, and that number has grown over the last two decades.

Nurse Practitioner 78

Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a cluster stepped wedge randomized trial? Long overdue.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

APRIL 14, 2022

So for those of you listening via YouTube, here’s the live version for those of you who are listening on the podcast, you’re going to get my prerecorded version with lots of loops and I’m doing consultation with my new music teacher who’s a music producer in LA. This is both a research and a clinical interest of yours.

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

FEBRUARY 13, 2025

You did a rural tele-palliative care consultation study. And so the video consult was what became the mode. Marie 03:42 So probably the most important thing is we developed the consultation as a culturally based consultation process. And then we incorporated that information into the consultation process.

Consulting 63

Consulting Community Patient-Centered Families 63

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. We tested two different nudges individually and then we combined them. What is sludge? I highly encourage you. Kate 13:59 What did we do?

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

GeriPal

DECEMBER 19, 2024

So we’re going to be talking about palliative care for individuals with mental illness. Eric 07:03 Yeah, it’s hard because you can also think about it, let’s say, because we see palliative heart failure clinics. Eric 12:11 And we consult psychiatry. Oh, yeah, yeah. Good artist. Really tasteful. Alex 40:57 Yeah.

Illness 101

Illness Mental Health IT Patient-Centered 101

GeriPal

MARCH 7, 2024

It sets space between us and the individuals we’re trying to take care of. I think that consistency of what is the expectation of our roles is crucial in a lot of ways, but that role is determined by the individuals we’re serving. Eric: When I try to think about what a doula does, should I call it a consult?

Provider 117

Provider Illness IT Healthcare 117

GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? If they get palliative care consult, they get one.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

JULY 20, 2023

We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. But in California where I practice medical aid and dying is legal and similar to other issues that are controversial in some places, many physicians do not prescribe or do visits for medical aid and dying consultations.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73