FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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FDA Law Blog

MAY 7, 2025

The government asserted that Marchetti had relationships with, access to, and influence over doctors, but failed to show that Marchetti exercised any impermissible influence on them. As such, neither Sorensen nor the entities he paid had any authority to act on behalf of a physician or unduly influence[d] the doctors decisions.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

OCTOBER 2, 2023

Several of these approvals, including examples in which we were directly involved—Relyvrio for ALS and Skyclarys for Friedreich’s Ataxia—expanded upon the examples FDA previously provided to illustrate their interpretation of the single study plus confirmatory evidence statutory standard (see our earlier blog posts here and here ).

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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 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. The practice of medicine was viewed as paternalistic. 3, 2020).

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

FEBRUARY 14, 2023

Gaulkin & Riëtte van Laack — Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.

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FDA Law Blog

SEPTEMBER 6, 2022

Although a sponsor of an individual patient expanded access trial may only recover direct costs associated with making the drug available, a sponsor of an intermediate-size patient population expanded access IND, or a treatment IND may also recover administrative costs directly associated with the expanded access use.

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Clinic Manufacturing Patients IT 52

Pamela Wible MD

JUNE 20, 2025

Characterized by cynicism, exhaustion, and reduced job satisfaction, physician burnout can lead to devastating personal and professional consequences, including strained relationships, substance abuse, early retirement, and even suicide. Individuals with moral injury may see themselves and the world as immoral and irreparable.

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FDA Law Blog

DECEMBER 12, 2022

intrusion [into] the doctor-patient relationship. FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval. In addition, the Checklist is not device-specific and may not reflect the data contained in the manufacturer’s premarket approval application (PMA). This proposal is a[n].

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Manufacturing Provider Patients IT 52

FDA Law Blog

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

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PEMBlog

OCTOBER 2, 2024

Now, I know that’s a lot to digest, and you might be starting to churn, but let’s talk now about the relationship between eating and pain. In individuals with celiac disease, gluten intake leads to an immune mediated inflammatory response that damages the small intestine’s mucosal lining, specifically the villi.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

GeriPal

FEBRUARY 29, 2024

Widera and Smith have no relationships to disclose. Guest hosts Lynn Flint and Anne Kelly have no relationships to disclose. I actually wrote a blog post about this when we were a blog. We were a blog? I’m most proud that when we started the blog, there was some tension between Geriatrics and Palliative care.

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GeriPal

AUGUST 31, 2023

He studies the mental health system in the ways in which it has failed children and adolescents, and he writes about his experience with cancer in a blog, the Billgardner.substack.com, Billgardner, one word. ” Somebody in the comments on their blog response said, “Did you check the date? Bill: Thank you. Brad: Thank you.

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GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. And you wrote, actually, a beautiful GeriPal blog about it a while ago.

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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. Applying a critical race lens to relationship-centered care in pregnancy and childbirth: An antidote to structural racism. Health Affairs Blog. See Reference 20 below for additional information. 2020;47(1):3-7.

Community 52

Community Patient-Centered Families Family 52

GeriPal

SEPTEMBER 22, 2022

And maybe you’ll say the wrong thing, maybe you’ll do the wrong thing, and that’s part of human relationship as well. But nobody has had an opportunity to really get to know them and have a relationship, any kind of rapport built with them, and then things blew up over something, and now you had no rapport.

Illness 102

Illness IT Patient-Centered Patients 102

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. You did write a blog post about him though, Eric. A few Dignity Therapy- Harvey Max Chochinov links. SPONSOR: .

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GeriPal

MARCH 30, 2023

I started blogging as a patient, just talking about my own story online like patients did back in the day. I was like maybe I’ll write a blog post about this later. I’m going to try to remember as much as I can, so when I wake up, can I write a … My thought was I’m going to write a cool blog post about this.

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IT Patient-Centered Patients Healthcare 96

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. Although the Act limits DEA’s authority over cannabis research protocols, it does not limit HHS’ authority, including over changes in the method of administration, dosing and the number of individuals involved in research.

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Medical Manufacturing Electronics Provider 64

GeriPal

DECEMBER 15, 2022

Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. You would love this because in that story that was in that patient CHR was a particular song that had meant a lot to this individual. Tell me about your illness.

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IT Patient-Centered Healthcare Illness 106

GeriPal

JANUARY 11, 2024

** Claim your CME credit for EP293 “What’s Up With MAID in Canada” [link] Note : If you have not already registered for CME, you can register here [link] For more info on the CME credit, go to [link] Disclosures: Moderators Drs Widera and Smith have no relationships to disclose. You’re on mute, Bill.

Illness 144

Illness IT Medical Provider 144

Family Medicine Initiative

APRIL 10, 2024

This graph illustrates that the benefit of long-term GP-patient relationships is even dose-dependent (longer GP-patient-relationship = lower risk of dying prematurely): Why do long-term GP-patient relationships improve health and reduce costs? 11 , 13 Over time, GPs come to know their patients well.

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GeriPal

JUNE 29, 2023

I am there with individuals who are dying. Religion is important to me and my relationship with God has got stronger since I’ve been working here. Alex: And just of note, you can see our pictures if you go to our blog post and YouTube website, you can see this is a magnificent, beautiful garden space. So that touches you.

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GeriPal

SEPTEMBER 19, 2024

Alex 21:31 Blog post, if we’re talking about the same study, was like, fast food palliative care, in and out palliative care, something like that. Or the article that, the fast food article, to use the parlance from the blog post. It’s about establishing a relationship and rapport. This is Eric Widera.

Patient-Centered 120

Patient-Centered IT Patients Hospital 120

GeriPal

DECEMBER 12, 2024

And really they’re trying to understand what reasonable quality of life can this person expect to achieve and just agonizing over those decisions, over every individual decision. Widera and Smith have no relationships to disclose. Guests Dave Wendler, Jenny Blumenthal-Barby, and Teva Brender have no relationships to disclose.

Patient-Centered 110

Patient-Centered IT Patients Healthcare 110

FDA Law Blog

MAY 26, 2025

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Such a message may understandably deter the targeted conduct to avoid such a risk. See 21 U.S.C.

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Manufacturing Provider Medical IT 59