FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

Clinic 59

Clinic IT Provider Patient-Centered 59

33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. Some will convert their practice into a virtual clinic with late night pajama time ‘sessions’ while others will recognize the need for guardrails. Pretty simple.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Average Number of Industry Days to MDUFA IV Decision 54.69

Provider 75

Provider IT Engineering Medical 75

GeriPal

JANUARY 12, 2023

After coming out of residency and taking care of lots of complicated older adults as of now, a brand new physician attending, I really needed that team to help me out. Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics.

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101

GeriPal

JUNE 8, 2023

-@AlexSmithMD Additional Links: – Fingerstick monitoring in VA nursing homes (too common!) – Improving diabetes management in hospice – Continuous Glucose Monitoring complicating end of life care Transcript Eric: Welcome to the GeriPal podcast. Alex Smith: That’s a compelling clinical argument… Tamryn: It is.

Diabetes 74

Diabetes Management Patient-Centered Families 74

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

Mental Health 52

Mental Health IT Medical Specialization 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. Once the need for labor was largely met, anti-Chinese narratives (e.g.,

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. Some SCN neurons were activated by light, while others were inhibited.

Provider 109

Provider Medical Complication Diabetes 109

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. It used to be a much more complicated model. And not just statistically significant, but clinically meaningful. David: Right.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

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 clinical decision support? Long overdue.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

MAY 26, 2022

Another area where this came up that I think has to just be clearly reciprocity is that people who were volunteers or clinical trial participants were often prioritized to some extent for COVID 19 vaccines. And on the prioritization front, I think we ended up being pretty skeptical.

Vaccination 88

Vaccination Individual IT Healthcare 88

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 133

Patient-Centered Hospital Patients IT 133

GeriPal

MARCH 30, 2023

Then in the OpenNotes work that I do, I was hired to take something complicated like transparency and patients having access to their full records in medicine, and then making that something that the lay public understood. This was in May of 2020. It looks very, very different today than it did then. What happened here?

IT 96

IT Patient-Centered Patients Healthcare 96

GeriPal

OCTOBER 19, 2023

It’s like how liberating it is to eliminate resentments, regrets and envy from our lives and how great it is in our clinical practice when we’re able to help families reconcile after an estrangement, how much relief that brings. Eric: That’s a complicated form then. I think it was Bob Lee’s 2020 JAGS paper.

Patient-Centered 127

Patient-Centered IT Patients Illness 127

GeriPal

FEBRUARY 8, 2024

She softened to her suffering, and she trusted me enough to have a moment, that she could look into that and see that, yes, she had her clinical judgment, which was fine, but also that there was another processes going on, which was her own suffering. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs.

IT 137

IT Families Family Physicals 137

GeriPal

FEBRUARY 13, 2025

And we had a greater decrease in symptom intensity at day seven versus the usual care group by both a clinically meaningful and a statistically significant difference. But again, hindsight’s 2020 probably wasn’t the best measure to look the other one we tested in an exploratory way was feeling heard and understood.

Consulting 64

Consulting Community Patient-Centered Families 64

Family Medicine Initiative

APRIL 10, 2024

On average, twice as many patients have contact with GPs than with all specialists (in offices and/or outpatient clinics) combined. 29 Source: OECD Health Statistics 2020 (without dental care) 29 8. GPs improve chronic disease management, which prevents complications. of healthcare costs in the EU 2018.

Family Physician 130

Family Physician Families Family GP 130

FDA Law Blog

JUNE 21, 2022

In that legislation, Congress instructed FDA to publish proposed OTC hearing aid rules by August 2020 and to finalize those rules within 180 days after the closing of the public comment period for those proposed rules. We are approaching 5 years since Congress directed FDA to issue the OTC rules.

IT 52

IT Provider Government Patients 52

GeriPal

NOVEMBER 3, 2022

What I often hear, grief, that normal, often, and we just had Holly Prigerson on the podcast talk about complicated grief, but grief in itself, that reaction, that is often triggered by loss. And then to see her show up in our hospice unit in April of 2020, it just completely broke my heart. Eric: And how does that differ from grief?

Healthcare Professional 103

Healthcare Professional Healthcare IT Relationship 103

Tiny Physician

OCTOBER 17, 2021

Treating with sugar pills : why homeopathic principles are unscientific Arsenicum album lacks evidence from randomized controlled trials Image taken from zeenew.india.com If you take the pain to search “Arsenicum album” in PubMed, you will find hardly 3 clinical trials conducted on this medicine. References 1.

Vaccination 52

Vaccination Government Physicals IT 52

GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. 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. Annals of Int Med. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 16, 2024

And if we’re seeing somebody in the clinic, how they might be able to do things in four years, we’re looking ahead to try to slow any progression down. If you are concerned that your silence can be a form of complicity and bad behavior, too, we have a certain amount of expertise. Ken 05:40 That’s right.

Diagnosis 141

Diagnosis IT Diagnose Physicals 141