FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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Manufacturing Provider Medical IT 98

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.

Provider 75

Provider IT Engineering Medical 75

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.

Community 52

Community Patient-Centered Emergency Room Medical 52

GeriPal

MARCH 24, 2023

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. She happened to focus on some specific for-profit hospice providers.

IT 115

IT Provider Patients Families 115

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. James 00:32 Good afternoon.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. People with dementia make up about half of hospice admissions. Transcript. This is Eric Widera.

Families 107

Families Family IT Patients 107

GeriPal

APRIL 26, 2024

Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 Alex: We are delighted to welcome Bryanna Moore, who is a philosopher and bioethicist, and she’s at the University of Texas Medical Branch where she also directs the clinical Ethics Fellowship. Bry: Yeah, Eric.

Patient-Centered 121

Patient-Centered IT Patients Consulting 121