FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court held that it does.

Clinic 111

Clinic IT Patient-Centered Consulting 111

The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Dr. Kevin M.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

Mental Health 98

Mental Health Management Patient-Centered Finance 98

FDA Law Blog

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.)

Provider 64

Provider Manufacturing IT Medical 64

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. It’s also a lot what stage of career they are. Beth: Yeah. Greg: Yeah.

Board-Certified 110

Board-Certified IT Primary Care Referral 110

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution.

Illness 107

Illness IT Patient-Centered Patients 107

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Ganetsky M (ed).

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. I think even the word patient, patient, I think, comes from the word suffer, the one who suffers. More of the point is we get in big trouble with ourselves and with our patients and each other if we go down that comparison track too far, I think that we can cause some real trouble there.

IT 137

IT Family Families Physicals 137

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. Randomized controlled trials of chaplaincy interventions.

IT 99

IT Patient-Centered Family Families 99

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. Randy died February 26, 2023. It’s really special to be here and to be talking about this paper, which was really important to Randy. Welcome, Bob. Bob: Thank you.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

Mental Health 116

Mental Health Community IT Screening 116

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.” Care Ecosystem.

Patient-Centered 125

Patient-Centered IT Family Families 125

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73