FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years. By Sarah Wicks & James E.

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Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic Community 52

FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

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Diagnosis Clinic Provider IT 59

PEMBlog

SEPTEMBER 24, 2024

At that point, he was referred to pulmonology who started the patient on albuterol, manual chest physiotherapy, and a steroid inhaler with a plan for a fourth chest x-ray four weeks later. On arrival, the patient was febrile to 38.3C. Bronchopulmonary sequestration Our patient was diagnosed with bronchopulmonary sequestration (BPS).

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Diagnosis Diagnose Patients Asthma 52

The Clinical Problem Solvers

AUGUST 25, 2020

Heightened police presence in communities of color can be perceived as a threat by community members which can result in sustained increases in stress and cortisol levels. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R. This includes thinking about our roles as mandated reporters and police presence in emergency departments.

Community 52

Community Patient-Centered Relationship Education 52

GeriPal

MAY 19, 2022

A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). Dr. Akhila Reddy and colleagues study looking at converting hospitalized cancer patients from IV hydromorphone to PO morphine, PO hydromorphone, or PO oxycodone. It depends on the clinical situation. How do you do that?

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IT Patients Individual Relationship 139

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act did not limit the ability to prescribe controlled substance medications by telemedicine so long as the patient and prescriber had a least one in-person visit. a prescriber that engages in telemedicine with the patient), including a review of PDMP data for the past year. 21 U.S.C. § 802(54)(D)(i).

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Telemedicine Telecommunication Telehealth Medical 59

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. A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or.

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Lab Testing Individual Referral Patient-Centered 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. 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. Goldilocks zone).

Diabetes 74

Diabetes Management Patient-Centered Family 74

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. A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

The Clinical Problem Solvers

FEBRUARY 8, 2023

Identify realistic solutions to drug policy reform that promote health equity among marginalized communities living in the United States. Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

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Nurse Practitioner Family Families Primary Care 52

The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison, a community organizer and trans theorist, and Dr. Psyche A. Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. During this episode, we hear from Da’Shaun L. is rooted in anti-Blackness.

Community 52

Community Manufacturing Patients Medical 52

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. Going into patient’s homes was eye opening. So Carmen and Katie developed an EMS Community Partnership program. Word of mouth spread rapidly.

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Community Transportation IT PCP 116

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? Welcome back, William. William: Thanks so much.

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Patient-Centered IT Patients Clinic 130

Physician's Weekly

JUNE 11, 2025

The systematic review of peer-reviewed intervention was published from 2018 to 2023. The researchers recommended including community members in intervention design, healthcare systems, and policies. This message should be incorporated into counseling during routine clinic visits, especially for people recently diagnosed with HIV.

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Mental Health Healthcare Professional Community Healthcare 114

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. They just kept at it.

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Medical IT Patient-Centered Healthcare 100

The Clinical Problem Solvers

MAY 30, 2022

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. The exact statistics vary by location and by the overall level of investment in services such as childcare and parental leave within each community.

Community 52

Community Patient-Centered Family Families 52

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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Screening IT Family Families 121

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. Fam Med Community Health. 3 To respond to this crisis, the U.S.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

FEBRUARY 6, 2025

So let’s just say you have a healthy 55 year old or 65 year old in your clinic. That screening influences kind of further treatment, actually, probably more importantly, patient outcomes. So I’m in a specialty clinic, so I’m in this interdisciplinary memory assessment clinic. Nate 05:29 Ooh.

Primary Care 97

Primary Care Diagnosis Screening IT 97

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really? And so we did this song.

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IT Hospital Screening Patients 65

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Initially, it was just because there weren’t really answers for my patients.

Family 102

Family IT Families Diagnosis 102

GeriPal

JUNE 22, 2023

Michele: Yeah, so in May of 2018, there was an article by Suleika Jaouad in the New York Times Magazine, and they spent about two weeks in our hospice with us learning about the work that’s done. Michele: The article was 2018, but I think Bonnie read the article more recently. It’s by choice, just like in the community.

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Family Families IT Community 133

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Susan: I will share in Indiana, we actually had that as our legal model, that there was a decision making by committee up until 2018. Alex: What did it changed to after 2018? We can work it out! AlexSmithMD. Transcript. Eric: Welcome to the GeriPal Podcast. Rebecca: Agreed.

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. I want to say like 2017, 2018, something like that.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. I’m also a geriatrician and a palliative care physician, so I’ve talked to families and patients about death and dying.

IT 123

IT Patient-Centered Patients Relationship 123

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

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Is that right?

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. Isn’t that what we always work with, with patients, with our colleagues, with ourselves? I think that in almost every clinical encounter, we struggle with what’s ours and what’s someone else’s?

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Patient-Centered IT Community Illness 93

Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Nonetheless, its work has often been politically unpopular and unheralded outside of a small community of health services researchers and patient advocates.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. Pamela Wible soon discovered why. Let’s hear it for you guys.

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Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 17, 2025

Until recently, the only treatment was growth hormone therapy to help patients stay leaner and grow taller, but it didn’t address appetite. This breakthrough for these patients comes as other drugs are revolutionizing how doctors treat obesity, which affects more than 40% of American adults.

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52

PEMBlog

DECEMBER 4, 2024

We will review the clinical presentation, diagnostic strategies, management protocols, infection control practices, and vaccination updates. Learning Objectives Understand the clinical progression of pertussis through its three distinct stages and identify key symptoms, including age-specific presentations in infants and older children.

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IT Vaccination Diagnosis Complication 52

FDA Law Blog

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. A qualified medical professional must perform the refill; it cannot be done by the patient. 2] Why is this an issue?

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IT Medical Patients Specialization 98