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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Priority Physicians

JANUARY 27, 2025

Many of us know where our meals come from, have sufficient clothing, enjoy roofs over our heads, access heating and air conditioning, use reliable transportation, and receive effective medications. of adults in the state showed significant symptoms of anxiety or depression in 2023. So why is the general population so anxious?

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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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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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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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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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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This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.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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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? Yael 02:12 Thank you. I’m excited.

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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. Ali John 11:34 Yep.

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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

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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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. English elite.

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GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” These studies are important.

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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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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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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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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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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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Physicians News Digest

MAY 12, 2025

31 that a New York physician had been indicted for shipping abortion medications to a woman in Louisiana, it stoked fear across the network of doctors and medical clinics who engage in similar work. 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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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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GeriPal

OCTOBER 31, 2024

Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. 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.

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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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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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