FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

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FDA Law Blog

MAY 8, 2023

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). (C) 18 U.S.C. § EKRA Issue. 18 US.C. §

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FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). (C) 18 U.S.C. § EKRA Issue. 18 US.C. §

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GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. We’re doing a lot of interactive relationship building. You can do this many different ways, but the first one is a little bit more structured, like an assessment that we’re all familiar with clinically.

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The Clinical Problem Solvers

DECEMBER 20, 2021

Appreciate how intergenerational trauma may surface amongst Asian-Americans, and how these intergenerational relationships may also offer fertile ground for generating understanding. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures.

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Community Patient-Centered Relationship Healthcare 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. One example that is presented involves the complicated relationship between the United States and Chinese immigrants and farmworkers in California.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

This is the last of three episodes interrogating the relationships between race, place, housing, and health. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. link] Homeless community in San Diego resists police terror and demands safe housing – Liberation News Lopez, M., Rothstein, R.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. is rooted in anti-Blackness. Williams-Forson and Da’Shaun L.

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GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. Mike: 2019. Eric: 2019. So in those clinical situations, you should consider avoiding that drug. You have to take that into consideration clinically.

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Medical IT Patients Clinic 97

The Clinical Problem Solvers

MAY 30, 2022

Applying a critical race lens to relationship-centered care in pregnancy and childbirth: An antidote to structural racism. Published January 16, 2019. Published April 10, 2019. Published March 11, 2019. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. 2020;47(1):3-7. doi: 10.1111/birt.12462

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Community Patient-Centered Family Families 52

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

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Patients Clinic Patient-Centered Illness 73

GeriPal

NOVEMBER 2, 2023

Jerry: Probably for the reason a lot of people go into geriatrics, close relationship with grandparents, volunteered to work in a nursing home as a high school student, just felt really good about being around old people and not having a problem with it. I finished my fellowship in ’88. Why did you go into it?

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GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

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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.

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GeriPal

DECEMBER 5, 2024

It’s that mixture of intimacy and vulnerability, of shared clinical experiences, that fosters a sense of belonging. We definitely draw on the sciences, on biomedical science, on clinical trials, on pharmaceutical design and all sorts of things like that. It was late on a Friday afternoon in December 2019. Eric 04:44 Yeah.

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IT Community Patients Families 107

GeriPal

APRIL 18, 2024

Alex: In 2019 … You wrote two viewpoints about AI recently in JAMA, relatively recently. I guess, 2019, and then, one again about last month or so. And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” That is the first clinical use case. Eric: Yeah.

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GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” Widera and Smith have no relationships to disclose.

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GeriPal

APRIL 26, 2024

Widera and Smith have no relationships to disclose. Guest Betty Ferrell has no relationships to disclose. 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.

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The Clinical Problem Solvers

MAY 2, 2023

Naweed Hayat, a child and adolescent psychiatry fellow at the University of California San Diego, who applies his own lived experience of resettlement to his clinical practice. Identify the role of trauma-informed, culturally-responsive care for refugee, asylee, and immigrant populations and how it can be operationalized in clinical practice.

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