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

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §

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FDA Law Blog

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)).

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FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.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. 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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GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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Medical IT Patients Clinic 97

The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Watts remind healthcare providers to speak out about the structural causes of homelessness. Push back against individual narratives that blame individuals for systemic injustice.

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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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The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

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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. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. And so it pops up and if you’re a different prescriber from a different healthcare system, you can still see if people have filled it, it’s limited to the amount of fills you can get in the amount of tablets or capsules you can get in a month.

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The Clinical Problem Solvers

OCTOBER 11, 2021

These gaps are not a product of lifestyle choices, biology or individual behaviors. They are a product of deep-rooted man-made policies that extend to many sectors (healthcare, education, criminal justice etc). Association of Social and Economic Inequality With Coronavirus Disease 2019 Incidence and Mortality Across US Counties.

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GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Or is that your medications causing that? Or does it?

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Patient-Centered Community IT Medical 91

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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Board-Certified IT Community Medical Student 91

GeriPal

APRIL 13, 2023

Julianne: It’s interesting because I think I read somewhere that a finding in science often takes about, on average, 17 years to make it into medical practice. We’ll talk about is it in medical practice yet? She tried to extend conversations beyond what was medically, I think, necessary for the encounter.

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IT Community Patient-Centered Medical 99

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. So medication adjustments.

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Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. I think that’s the part that’s still the fundamental foundation of hospice, individualized care plans focusing on patients, families, wants, needs and goals. Lauren: Thanks for having me.

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. Cocktail Medications.

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GeriPal

FEBRUARY 27, 2025

Alex 00:27 And we’re delighted to welcome S a ch Kale, who is a palliative care doc at the Ohio State University Wexner Medical Center. But my medical training kicked in. For those individuals, how do you think about that? Or they might, you know, they might sell their medication, which this population is also prone to.

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Patients Clinic Patient-Centered Illness 72

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. A recent state law failure-to-warn case in the SDNY makes that very point.

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GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. There’s also been some differences in things like staffing.

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Family Families IT Patients 106

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. employee-healthcare":{"type":"Static","pageId":"j7g7k"},"./skinwave":{"type":"Static","pageId":"r8t69"},"./about-3":{"type":"Static","pageId":"lyck3"},"./frequently-asked-questions":{"type":"Static","pageId":"ipt4q"},". Lets live healthy and whole, TOGETHER!”

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BMJ

AUGUST 20, 2021

Increased health anxiety has been a feature of the pandemic, with fears around leaving the home, social distancing, hand hygiene, and shortages of goods and medications due to panic buying commonplace. Despite the spike in prescribing of insulins, oral antidiabetic medications were not similarly affected.

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Primary Care Supply Chain General Practitioner Vaccination 40

FDA Law Blog

OCTOBER 29, 2023

This occurred in January 2022 when the Departments issued additional guidance , which discussed reports of denial of coverage in violation of the ACA requirement and provided a reminder to plans and issuers of their responsibilities under the statute and 2019 HRSA Guideline (FAQ Part 51, Q9).

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Individual Insurance Healthcare Provider 45

FDA Law Blog

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families.

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Healthcare Provider Clinical Practice Clinic 52

GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. I took my kids in 2019, 2020. He wanted the best in the world to be able to play the game. It isn’t the only.

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