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

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 52

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clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year.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

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” SCOTUS has until Dec.

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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. The practice of medicine was viewed as paternalistic.

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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

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

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. It’s also a lot what stage of career they are.

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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

The Clinical Problem Solvers

MAY 30, 2022

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center.

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Community Patient-Centered Family Families 52

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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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

BMJ

FEBRUARY 8, 2021

Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., Increased quality of patient-provider communication, including offering behavioral counseling when needed, may avert unnecessary prescriptions. Hyattsville, MD: National Center for Health Statistics.

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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? Why am I having difficulty with this patient? Why am I feeling frustrated with this patient?

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Patients Clinic Patient-Centered Illness 73

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? Has kept me interested, the patient experience and the older adults in the community, their experience.

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IT Community Patient-Centered Medical 99

BMJ

MAY 10, 2022

Family physicians and family health workers, considered reliable sources of vaccine information, have a unique position where individuals in rural and urban areas can access frequently, uninterruptedly, cheaply, and easily [2]. A sample was not selected as it was aimed to reach all 323 people working in family health centers in the district.

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GeriPal

NOVEMBER 2, 2023

We have the new geriatric surgical verification process where they’re, I think now eight or so level one geriatric surgical centers with 40 more somewhere in that process of becoming certified. And he asked me questions like, “Why is this patient in bed? So now we have geriatric emergency departments.

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Board-Certified IT Community Medical Student 91

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 54

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

FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. Controlling Drug Price Increases.

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