FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Medical information about a patient. Other medical information.

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The Clinical Problem Solvers

JANUARY 18, 2021

Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue. The Clinical Problem Solvers Podcast.

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FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

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FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Conducting a second investigation that tests the same fundamental principles (e.g.,

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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. § 220(e)(2). 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2).

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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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 29, 2022

It explains that “FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., randomization, blinding).” Fiscal Year. Total Requests Received. Granted .

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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. § 220(e)(2). 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2).

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Lab Testing Individual Referral Patient-Centered 40

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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Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s Without a fix, drug companies are incentivized to seek the broadest orphan drug designation as possible and then focus clinical studies only on the narrowest patient populations that would support approval.

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FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA. Average Number of Industry Days to MDUFA IV Decision 54.69

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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. ” Eric: It strikes me that there also seems to be a difference between coaching a team, like many of us are familiar with, and this individual coaching, although there may be group coaching as well. We learn in context.

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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

Annals of Family Medicine

NOVEMBER 20, 2024

Using linked administrative databases, we identified all instances of PIP-AP according to the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as ED visits and hospitalizations. Residents were followed for 1 year or to date of death, whichever occurred first.

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The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Creating spaces where these experiences can be shared by patients as well as by practitioners can highlight the structural nature of seemingly individualized problems.

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Community Patient-Centered Relationship Healthcare 52

Physician's Weekly

JUNE 22, 2025

Males had higher levels of urinary mast cell mediators—LTE4, 2,3-BPG, and tryptase—particularly in atopic individuals, compared to females. These sex-based differences suggest the need to account for sex in interpreting diagnostic biomarkers for mast cell and atopic disorders.

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The Clinical Problem Solvers

APRIL 5, 2022

Push back against individual narratives that blame individuals for systemic injustice. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. If we are not part of the solution, we are complicit in structural injustice. Push back against dehumanizing language. Rothstein, R. April 5, 2022.

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Physician's Weekly

JUNE 21, 2025

Preventive measures such as timely vaccination against hepatitis viruses also remain crucial in reducing the burden and complications of liver disease. Variceal glue therapy with non-selective β blockers (NSBB) is a standard approach for managing acute fundal variceal bleeding and reducing rebleeding risk in individuals with cirrhosis.

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The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. The Clinical Problem Solvers Podcast.

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Government Community Education Individual 52

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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The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published January 16, 2019. Published April 10, 2019. Published March 11, 2019. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. Published online August 2020. link] Katy B.

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Community Patient-Centered Family Families 52

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. I’m part of a clinical trial that’s housed at the Lundquist Institute down at Harbor-UCLA.

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BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., 2019-1372.

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Medical Holistic Care Healthcare Healthcare Professional 40

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

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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Illness IT Patient-Centered Patients 107

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. I understand that it can be a hard place clinically. Cochrane Database of Systematic Reviews Review.

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Patient-Centered IT Healthcare Medical 96

GeriPal

NOVEMBER 2, 2023

So a couple weeks after it was published, I took a trip to a medical school in the western part of the country and I was visiting to think about their geriatrics research program, and they had a geriatrics evaluation clinic. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what?

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GeriPal

MARCH 24, 2023

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. On the other side, there’s another group that thinks, you know what?

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Medical Xpress

JUNE 8, 2025

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. However, we do not guarantee individual replies due to the high volume of messages. One of these sites does not use sucrose for acute pain management.

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IT Management Vaccination Medical 54

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. My interest in this paper and this topic goes back a long time and is based on my clinical experience as a hospice nurse, where I was taking care of what I felt like and what we’ve confirmed with research is about half of my patients.

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FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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BMJ

JUNE 25, 2021

1 Clinical guidelines internationally recommend statin therapy for both primary and secondary prevention of CVD, making statins one of the most frequently prescribed drugs in industrialised countries. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time.

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Primary Care Clinical Practice Electronics Clinic 40

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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Healthcare Provider Clinical Practice Clinic 52

PEMBlog

APRIL 4, 2025

The episode emphasizes thoughtful, individualized care in the context of rising vaccine hesitancy and declining immunization rates. Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? So what are we gonna go over in this episode? Interesting.

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Vaccination Illness IT Clinic 66