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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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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., Use of this single study authority has been crucial to breakthroughs in drug development for rare and serious conditions including those with unmet medical needs.

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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

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

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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

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FDA Law Blog

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions. randomization, blinding).”

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

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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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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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). 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.

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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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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

APRIL 5, 2022

Do you have a medical respite center? Push back against individual narratives that blame individuals for systemic injustice. Calac, Victor A. Lopez-Carmen, MPH, Naomi F. Know your community resources. Our guests emphasize that physicians must be familiar with community resources. Can you refer your patient there? 3.

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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. provision in only English +/- Spanish), limitations of medical technology (i.e., provision in only English +/- Spanish), limitations of medical technology (i.e.,

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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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The Clinical Problem Solvers

OCTOBER 11, 2021

These gaps are not a product of lifestyle choices, biology or individual behaviors. Association of Social and Economic Inequality With Coronavirus Disease 2019 Incidence and Mortality Across US Counties. Structural competency: theorizing a new medical engagement with stigma and inequality. The Clinical Problem Solvers Podcast.

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder.

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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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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. Eric: You’ve timed it perfectly.

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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. So medication adjustments.

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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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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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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. Welcome back to GeriPal, Lauren.

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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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The Clinical Problem Solvers

MAY 2, 2023

Together, our guests explain how trauma shows up in those who experience resettlement, and the role of trauma-informed and culturally-responsive care for refugee, asylee, and immigrant population in clinical practice. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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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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GeriPal

APRIL 17, 2025

Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. You know, I’m thinking about, like, you know, I think, Eric, you served on our medical school admissions committee once. I took my kids in 2019, 2020. And the uprooting of DEI is an act of violence. Well played. It is just impossible.

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