PEMBlog

OCTOBER 11, 2023

However, in pediatric patients whose pelvic bones are not fully developed, the bladder is more prone to injury. Clinical signs of bladder injury are nonspecific. Clinical signs of bladder injury are nonspecific. 2014 Aug;192(2):327-35. Epub 2014 May 20. Urotrauma: AUA guideline. doi: 10.1016/j.juro.2014.05.004.

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FDA Law

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. 2014); U.S. Stem Cell Clinic, LLC , 998 F.3d 3d 1314 (D.C.

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PEMBlog

OCTOBER 31, 2024

Why is this important for patients and caregivers ? A brief message from the principal investigator We studied close to a thousand patients with acute gastroenteritis in ten U. We found that probiotics did not improve patient outcomes when compared to placebo. 2018 Nov 22;379(21):2002-2014. N Engl J Med. Freedman et al.

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Adventures of a Sick Doctor

JULY 4, 2024

Must have had a rough clinic, I supposed; a family of 4 had gone in before me, and that is never good. Still though, he usually perks up when I come in, because he gets to show me my scans from November 2014 and compare them with now and we both applaud the wondrousness of the miracle that is my recovery. It was of course true.

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FDA Law

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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FDA Law

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law

JANUARY 30, 2025

They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines. Take steps to facilitate high retention including by incorporating patient perspectives into the design of such trials.

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FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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FDA Law

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March. This should serve as a reminder to submitters to carefully review their MDRs ahead of submission.)

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FDA Law

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

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Clinic IT Provider Patient-Centered 59

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. Let’s not waver on the truth.

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FDA Law

DECEMBER 11, 2023

The bottom line is this: without far better resource planning, this massive regulatory undertaking is going to be a disaster for all stakeholders, including FDA, industry, health care systems, providers and, most importantly, patients. 2, 2014), [link]. [12] Certain points are indisputable. 31, 2023), [link]. [10] 11] Jeffrey N.

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The Medical Futurist

JUNE 21, 2025

Self-care and telemedicine for patients The options of teledermatology services, as well as self-care platforms, are soaring. It is a win-win for everyone: patients do not have to wait in crowded waiting rooms for an exam, while dermatologists can deal with the easier cases in shorter time online.

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The Clinical Problem Solvers

MARCH 4, 2024

42:00 Abolitionist reimaginings of Health 55:05 Democratizing Narrative Medicine 1:03:05 Closing Remarks and Clinical Pearls Speaker biographies (Abbreviated) Zahra Khan is an educator and editor whose work emerges at the intersection of narrative, healing and disability justice, and liberation pedagogy.

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Community Education Patient-Centered Relationship 52

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? This is back in, I don’t know, like 2014 maybe. And then one patient who really knew more about a topic than I did, which unfortunately happens much more often.

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Medical IT Patient-Centered Healthcare 100

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. All of this contributes to various mental health challenges that are consistent with surveillance in not only a wider police-state but also the patient-physician relationship.

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Community Manufacturing Patients Medical 52

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals.

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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.

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GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Patient-Centered IT Hospital Patients 78

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. Initially, it was just because there weren’t really answers for my patients. We’re going to go into how to talk to patients about this, because Emmy, you’ve done some research on it.

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GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. And yet, we know little about the clinical experience of people with dementia in hospice. People with dementia make up about half of hospice admissions. And I had a blast playing Take the Money and Run!

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Family Families IT Patients 107

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. Harding, M., Pediatrics.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

37:50​ Race vs. ancestry vs genetics–implications for research and clinical practice 52:02 ​What can we start doing tomorrow? How is racism causing the outcomes that I am seeing in my patient? Ignoring race and racism does not negate the profound impact that race and racism have on our BIPOC patients’ health.

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. On clinical presentation. Available from: [link] Rice GM, Steiner RD.

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GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. And, of course, this is what families of patients undergoing palliative care go through. This is 24,000 encounters, over 15,000 patients, 11 hospitals, eight states.

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Consulting Hospital Patient-Centered IT 122

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. I don’t see a lot of those out there. Is that your grandchildren?

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IT Patient-Centered Family Families 99

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. 9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period.

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GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.

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PEMBlog

JANUARY 17, 2024

Camargo, Clinical Trial: Comparative Effectiveness of Cephalexin Plus Trimethoprim-Sulfamethoxazole Versus Cephalexin Alone for Treatment of Uncomplicated Cellulitis: A Randomized Controlled Trial, Clinical Infectious Diseases, Volume 56, Issue 12, 15 June 2013, Pages 1754–1762, [link] Liu C, Bayer A, Cosgrove SE, et al.

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PEMBlog

MAY 9, 2024

Nat Genet 2014; 46:1274. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. A pediatric neurologist.

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