FDA Law Blog

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. While this was a step in the right direction, only the tests whose clinical studies occurred during the Omicron surge had this stipulation included in their labeling.

Individual 97

Individual Clinic Healthcare Provider 97

FDA Law Blog

SEPTEMBER 26, 2024

What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock. CDRH takes great pride in stating that it is committed to innovation.

Clinic 64

Clinic IT Manufacturing Diagnosis 64

FDA Law Blog

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). lay users).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied: Patients with ≥1 visit between January 2018 and December 2019 and who remained in the cohort until at least May 2020. Intervention/Instrument: Disability status was identified from documented diagnostic codes from January 2018 to December 2019, and COVID-19 diagnosis was captured between April 2020 and December 2022.

Primary Care 130

Primary Care Patients Diagnosis Family Practice 130

GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. We make a diagnosis. The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life.

Board-Certified 110

Board-Certified IT Primary Care Referral 110

GeriPal

JUNE 8, 2023

If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? So my background clinically is working with cancer patients and families and those who underwent bone marrow transplant, and a lot of times for their treatment regimen, it includes steroids.

Diabetes 74

Diabetes Management Patient-Centered Families 74

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

FDA Law Blog

NOVEMBER 9, 2021

Unfortunately for Xlear, this is not the first time the FTC has taken notice of the company, as it sent a warning letter to them in July 2020 telling them to stop their unsubstantiated claims. They didn’t stop. This is also not the first time the FTC and DOJ has used the authority of the COVID-19 Consumer Protection Act.

Provider 52

Provider Government Diagnosis IT 52

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. I think it was Bob Lee’s 2020 JAGS paper. So it’s the goals that are important.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

Physician's Weekly

JUNE 24, 2025

Declining IMID mortality mirrors broader CVD improve­ments, suggesting shared care benefits,” wrote lead study author Issam Motairek, MD , of the Cleveland Clinic, and colleagues. From 1999 to 2020, the dataset captured 127,149 deaths in which CVD was listed among 281,355 IMID-related deaths overall. per 100,000 in 2020.

Patient-Centered 52

Patient-Centered Hypertension Management Diagnosis 52

GeriPal

JULY 6, 2023

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. 60% of all medical costs have nothing to do with your health diagnosis. And then, the system responds in turn. Do I have access to good food?

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

APRIL 21, 2022

Mike Rabow shares his award winning poem about coming out to the world about his diagnosis with multiple sclerosis. . I think that in almost every clinical encounter, we struggle with what’s ours and what’s someone else’s? So beginning, literally April 1, 2020 until now I started with one poetry recession a week.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Diane: Fantastic.

Patient-Centered 125

Patient-Centered IT Families Family 125

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. ” We put together a clinical pilot study.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 16, 2024

Ken Covinsky reminds us that we should not be making a diagnosis based on what we see on TV, and that if a patient’s daughter expressed a concern that their parent “wasn’t right,” we would conduct an in depth evaluation that might last an hour. But I think clinical concerns are legitimate to bring up. Ken 05:40 That’s right.

Diagnosis 141

Diagnosis Diagnose IT Physicals 141