FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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FDA Law Blog

FEBRUARY 5, 2024

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. When finalized, the Draft Guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials.

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Georgetown Pediatrics & Family Medicine

MARCH 16, 2022

The Apgar score is responsible for reducing infant mortality rates considerably and is still used today to assess the clinical condition of newborns in the first few minutes of life. Apgar was the first woman to become a full professor at Columbia University College of Physicians and Surgeons.

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Medical Xpress

JUNE 16, 2025

Explore further Fruit fly study provides a blueprint for the brains circadian clock 0 shares Facebook Twitter Email Feedback to editors Featured Last Comments Popular Decades after 9/11, PTSD remains a persistent burden for thousands of responders 3 hours ago 0 A single enzymatic switch steers cell fate in intestinal regeneration Jun 13, 2025 0 Brain (..)

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GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be. About us – Dignity in Care.

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GeriPal

APRIL 14, 2022

This is both a research and a clinical interest of yours. But that just didn’t really resonate with what I saw clinically which was that there was lots of suffering both in the patient, their family and on the clinical team and just felt it was really this space where I didn’t have a lot of evidence to guide me.

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Illness Patient-Centered IT Patients 103

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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GeriPal

NOVEMBER 2, 2023

So a couple weeks after it was published, I took a trip to a medical school in the western part of the country and I was visiting to think about their geriatrics research program, and they had a geriatrics evaluation clinic. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what?

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Board-Certified IT Community Medical Student 91

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. Working with our clinical decision support team and thinking about where that could be. She’s a clinical research coordinator trained for many years.

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IT Patient-Centered Healthcare Illness 106

GeriPal

JANUARY 16, 2025

I, for example, had one patient, I remember during my fellowship, I was in geriatrics clinic and had a very well read patient who came in and was reading a New York Times article, I think in the well section at one point. You know, baby boomer generation started to turn 65 and older back in 2011.

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Patient-Centered IT Patients Healthcare 110

GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

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IT Community Patient-Centered Medical 100

PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2011 Aug;58(2):145-55.

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Patient-Centered Patients IT Hospital 52

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. I understand that it can be a hard place clinically. JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.: AFP 2019 Gabapentin for chronic neuropathic pain in adults.

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Patient-Centered IT Healthcare Medical 96

Medical Xpress

JUNE 8, 2025

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely.

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IT Management Vaccination Medical 54

BMJ

JUNE 25, 2021

1 Clinical guidelines internationally recommend statin therapy for both primary and secondary prevention of CVD, making statins one of the most frequently prescribed drugs in industrialised countries. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time.

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Primary Care Clinical Practice Electronics Clinic 40

GeriPal

MARCH 16, 2023

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. In clinic, I’m helping what, hundreds or thousands. When I write, I learn a ton from that. And I tend to think of writing as my version of public health. Even if I write a scholarly article.

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IT Healthcare Professional Healthcare Transportation 106

GeriPal

DECEMBER 1, 2023

Summary Transcript Summary There is a growing push to change how we define Alzheimer’s disease from what was historically a clinically defined syndrome to a newer biological definition based on the presence of positive amyloid biomarkers. So too systolic hypertension in elderly people, clinical trials. Alex: That’s right.

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IT Clinic Illness Hypertension 117

GeriPal

JULY 7, 2022

And then once I came to the United States, I saw this whole different dimension of pain, because I started residency in 2011, this was really at the peak of the opioid prescription epidemic, if you may. And yet, if you look at our clinical approach to pain, it still remains quite basic. And I was an internal medicine resident.

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Patient-Centered Physicals IT Patients 106

Medical Xpress

JUNE 7, 2025

In clinical trials, no participants who received the injection acquired HIV. The long-acting shot may increase PrEP uptake, especially among those preferring injections over daily pills, but challenges remain in reaching underserved populations and ensuring equitable access.

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Vaccination Insurance Medical Diabetes 66

PEMBlog

JANUARY 17, 2024

2011 Mar;127(3):e573-80. Epub 2011 Feb 21. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011; 52:e18. Clinically, for both, you’ll see areas of skin erythema.

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IT Patients Diagnosis Clinic 59

PEMBlog

APRIL 4, 2025

Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So what are we gonna go over in this episode?

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Vaccination Illness IT Clinic 66

Physicians News Digest

APRIL 1, 2025

By Brett Kelman Five years ago, the CEO of one of the largest pain clinic companies in the Southeast was sentenced to more than three years in prison after being convicted in a $4 million illegal kickback scheme. But after just four months behind bars, John Estin Davis walked free.

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Government Insurance Patients Clinic 52