FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.

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Clinic Provider IT Patient-Centered 61

FDA Law Blog

OCTOBER 14, 2024

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.

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Clinic Patient-Centered Asthma Patients 59

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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Lab Testing Individual Referral Patient-Centered 40

GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. If they’re a beginning fellow, that’s a very different coaching situation than coaching the chief medical officer or the president of a medical center. Beth: Yeah. Eric: Well, Greg, are there themes?

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Board-Certified IT Primary Care Referral 110

The Clinical Problem Solvers

APRIL 5, 2022

Margot Kushel is a Professor of Medicine and Division Chief at the Division of Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center and Director of the UCSF Center for Vulnerable Populations and UCSF Benioff Homelessness and Housing Initiative. Do you have a medical respite center?

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Community Patient-Centered Emergency Room Medical 52

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. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

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Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

DECEMBER 20, 2021

[link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Understand how engaged community-based work, centered on trust and accountability, has supported the health of communities served by Oakland, CA’s Asian Health Service.

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Community Patient-Centered Relationship Healthcare 52

BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Tasce: Yes.

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Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 9, 2023

Early data on efficacy in patients with anxiety and demoralization are promising. Two of our guests today, Stacy Fischer and Brian Anderson, are involved in large multicenter trials of psychedelics for patients with advanced cancer (Fischer) or life-limiting illness (Anderson). Research is exploding. Welcome back to GeriPal, Stacy.

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Patient-Centered Community IT Medical 91

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. Ali John 11:34 Yep.

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Illness IT Patient-Centered Patients 107

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? We’ll talk about is it in medical practice yet? Eric: You’ve timed it perfectly. It came after engaging her.

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IT Community Patient-Centered Medical 99

GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I talked about lack of prestige and respect, and I talked about how healthcare system leaders and medical school deans don’t always seem to value the field of geriatrics.

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GeriPal

FEBRUARY 27, 2025

We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Who follows the patient once the cancer goes into remission? But my medical training kicked in. Why am I having difficulty with this patient?

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Patients Clinic Patient-Centered Illness 72

Medical Xpress

JUNE 8, 2025

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. However, we do not guarantee individual replies due to the high volume of messages. Your feedback is important to us.

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IT Management Vaccination Medical 53

FDA Law Blog

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

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Insurance Patients Manufacturing Patient-Centered 83