FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Complaint ¶ 57. (The

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Treatment Plan ER Government Patient-Centered 139

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.

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The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

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FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Priority Physicians

JANUARY 27, 2025

of adults in the state showed significant symptoms of anxiety or depression in 2023. Find a caring primary care doctor: As a direct primary care physician, I devote time to sit down with patients and learn about their lifestyles, hopes, desires, worries, and concerns. Can we learn how to stop fearing the future?

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PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. Centers for Disease Control and Prevention. link] Macri, Angela, and Crane, Jonathan S.

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Complication Patient-Centered Patients Clinic 83

PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. How to know if a patient is on it? Patients on emicizumab will have it listed on their medication list.

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Individual Patient-Centered Patients IT 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. While there indubitably exists a need to advance scholarship and theory, we must also ground ourselves in the day-to-day actions that can bring comfort and kindness to our patients.

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FDA Law Blog

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. It’s also a lot what stage of career they are. Beth: Yeah.

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The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

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Community Education Patient-Centered Relationship 52

Annals of Family Medicine

NOVEMBER 20, 2024

Affordable Care Act Medicaid Expansion and individual health insurance marketplaces), Latinos continue to have the highest uninsured rate of any racial or ethnic group in the United States. Results: Latina/o patients had more uninsured visits than other racial/ethnic groups in expansion and non-expansion states.

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GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. How should we care for unrepresented individuals in inpatient and outpatient settings? Is the patient in your descriptor?

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Patient-Centered IT Patients Healthcare 109

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. Ali John 11:34 Yep.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

AUGUST 17, 2023

The outlook on amyloid antibodies are looking brighter though in 2023. However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer.

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FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” By James E. Valentine & Charles D.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. I think even the word patient, patient, I think, comes from the word suffer, the one who suffers. More of the point is we get in big trouble with ourselves and with our patients and each other if we go down that comparison track too far, I think that we can cause some real trouble there.

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GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Alex: That’s great.

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PEMBlog

JANUARY 16, 2025

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Clin Toxicol (Phila) 2023; 61:453. Patients that use these will repeatedly use it throughout the day. References Perry H, Burns MM.

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Complication Patient-Centered Management Patients 52

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. Randomized controlled trials of chaplaincy interventions.

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GeriPal

NOVEMBER 2, 2023

We have the new geriatric surgical verification process where they’re, I think now eight or so level one geriatric surgical centers with 40 more somewhere in that process of becoming certified. Like this year, 287 geriatric fellows started in 2023, which really isn’t a big change over the last 10 years.

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Medical Xpress

JUNE 8, 2025

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. However, we do not guarantee individual replies due to the high volume of messages. Your feedback is important to us.

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IT Management Vaccination Medical 54

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. We talk a lot about people being unhoused, which I think takes the blame away from the individual and kind of de.

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Healthcare IT Community Illness 100

GeriPal

DECEMBER 29, 2022

Journal of Patient Experience. I mean, it’s something that frustrates me on a daily basis, the number of times that I’ve had to argue with patients and even my own grandparents. Prior to working with Lee, I was working at a senior center as a caregiver specialist. Geriatrics. December 2020. Transcript. Eric: Yeah.

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Family Families IT Patient-Centered 96

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Care Ecosystem.

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Patient-Centered IT Family Families 125

Medical Xpress

JUNE 8, 2025

The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. Although they make a vital contribution to saving lives, bystander rescues often expose untrained individuals to hazardous conditions without the training and equipment available to professionals. times, first aid 0.4

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Provider Community Medical Diabetes 54

Physicians News Digest

MAY 12, 2025

It’s frustrating,” said Angel Foster, co-founder of the Massachusetts Medication Abortion Access Project, a clinic near Boston that mails mifepristone and misoprostol pills to patients in states with abortion bans. It was unclear when those tests would come, and would it be against an individual provider or a practice or organization?”

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Telemedicine Family Families Patients 52

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

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Hospital Patient-Centered Supply Chain IT 115

GeriPal

OCTOBER 31, 2024

And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. And when you look at the numbers, actually last year in 2023, even though we’re in a recovery phase, there were more than 75,000 deaths. Let’s say for nursing home patients, older.

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Vaccination IT Patient-Centered Patients 127

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

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FDA Law Blog

NOVEMBER 18, 2024

He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023.

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Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

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Patient-Centered Hospital Diagnose Medical 52

Physicians News Digest

APRIL 17, 2025

in 2022, according to the Centers for Disease Control and Prevention. Harm to HIV, Vaccine Studies The NIH, with its nearly $48 billion annual budget, is the largest public funder of biomedical research in the world, awarding nearly 59,000 grants in the 2023 fiscal year. That’s when he got the notice from the NIH. “It

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