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.

Relationship 40

Relationship Provider IT Individual 40

FDA Law Blog

JULY 7, 2021

In 2018, a Massachusetts court upheld the use of GEDs in treating patients with SIB/AB, finding the device to be effective in treating refractory patients. FDA cleared 510(k)s for GEDs in the 1990s. In April 2020, JRC and the parents and guardians of its patients petitioned the D.C. Circuit Court of Appeals to overturn the ban.

Medical 52

Medical Patient-Centered Patients IT 52

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. S&G Labs has no contractual relationships with the entities that referred clients to S&G Labs. 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

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. 7, 2017).

Patients 52

Patients Patient-Centered Clinic 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. Livornese and Josephine M. The endpoints must be novel (i.e.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

JUNE 8, 2023

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. So learning more about how to inform providers on how to make decisions about de-prescribing based on prognosis, based on diabetes type, based on their oral intake and their goals.

Diabetes 74

Diabetes Management Patient-Centered Family 74

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 115

Community Transportation IT PCP 115

The Clinical Problem Solvers

FEBRUARY 8, 2023

A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives. One example that is presented involves the complicated relationship between the United States and Chinese immigrants and farmworkers in California.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Because how that is approached can have lasting effects on relationships, unfortunately. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. Eric: Yeah.

IT 102

IT Family Families Diagnosis 102

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. This policy reflects a societal belief that humans are not valuable unless they provide a service. Dr. Kozhimannil reminds us that birth is transformative and a gift to witness.

Community 52

Community Patient-Centered Family Families 52

FDA Law Blog

JUNE 8, 2022

It need not be a 1:1 relationship, but it does need to reasonably compare. Context matters not only to the substance of claims and safety information, but to the presentation of such information as well. Teacher’s Gonna Show You, How to Get an “A,” Or, Let’s Not Forget About 21 C.F.R. Are the branches of the learning tree.

Healthcare Professional 52

Healthcare Professional Relationship IT Education 52

GeriPal

MAY 12, 2022

And then there are a number of groups that go out in vans and cars and go out into the surrounding community of Kerala to provide care for patients who are in their homes. And I’ll share that my own relationship with my father, who was a doctor, was a complicated one. I’m not sure he would really approve.

Community 115

Community IT Relationship Healthcare 115

GeriPal

APRIL 24, 2025

I think they may not be likely to provide much benefit, but because they’re water soluble and you just pee it out, they’re probably not causing much harm, except for potentially financial harm if they’re very costly. It’s just that he was foregoing things that we think would have provided him more benefit.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. But I mean, I would also add that not all of the responses to the PGA, and to the provider part that is completed, are coming from the patient. John: You know, Eric, I think it’s a definite possibility.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

Tiny Physician

MARCH 30, 2022

A doctor-patient relationship is mandatory in the case and this can be proven by cross-checking the duty list or from the patient’s case sheet. For example, a doctor working at a primary health center may not able to provide adequate care for a pre-term newborn child. But, a dereliction of duty has not been established so far.

Hospital 52

Hospital Government Patient-Centered Medical 52

GeriPal

OCTOBER 3, 2024

I wonder if you could say a little bit more about the meta Institute in particular and what it is that clinicians today can do to learn, to be more present and learn about the need to be thoughtful and compassionate in the care that they provide people with serious illness. Much more about relationships has been my experience.

IT 122

IT Patient-Centered Patients Relationship 122

Family Medicine Initiative

APRIL 10, 2024

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. million people in 2018), shows that the longer you know your GP, the better off you are. Over time, communication improves.

Family Physician 130

Family Physician Family Families GP 130

GeriPal

AUGUST 17, 2023

There is a lot to digest with these draft clinical guidelines but the big change from the 2018 guideline is moving Alzheimers to a biological diagnosis (biomarker evidence only) not just for a research framework but now from a clinical one. And so I think they need to provide- Eric: So fellowships need to change.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. This is a poem that gets into this issue of, what is the clinician relationship to all that stuff that’s going on around us? So my only question is what my relationship will be to suffering.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

MARCH 27, 2025

And so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. And I think these conversations, and I mean that in a way that these conversations are designed to not just be had in isolation between a primary care provider and a patient.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

Manufacturing 59

Manufacturing Provider Medical IT 59