PEMBlog

OCTOBER 11, 2023

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

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FDA Law Blog

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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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. That was a good week.

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FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

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FDA Law Blog

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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PEMBlog

OCTOBER 31, 2024

2018 Nov 22;379(21):2002-2014. There were also no differences in the duration of diarrhea or vomiting, day-care absenteeism, or household transmission of symptoms. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. N Engl J Med. doi: 10.1056/NEJMoa1802598.

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The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. The Clinical Problem Solvers Podcast. 1:05:57 Outtakes Takeaways Name Racism for What It Is If we don’t explicitly say the word racism, and identify its historical context, then we are complicit in its denial. References Mentioned 01:55 Jones, C. Accessed January 11, 2021. 03:55 Jones, C.

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FDA Law Blog

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.

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FDA Law Blog

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.” In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g.,

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FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”

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FDA Law Blog

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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FDA Law Blog

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.” In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g.,

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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FDA Law Blog

APRIL 3, 2023

In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder. Vanda is also conducting clinical studies of a long-acting injectable form of its marketed drug Fanapt tablets, an anti-seizure drug. NDA or BLA) drugs. See our memo summarizing CMS’s regulation here. times that of Medicaid ( $98 billion and $38.1

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FDA Law Blog

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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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

APRIL 30, 2021

Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data.

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FDA Law Blog

APRIL 30, 2021

Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data.

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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. They’re suffering from moral injury.

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The Medical Futurist

JUNE 21, 2025

It was launched in 2014 as an iOS app , available in 6 languages, and among others, it offers an on-the-go skincare assessment tool as first-step guidance on skincare concerns. (*There are widely varying figures, ranging from 66% to 90% depending on the source of information.) Cureskin aims to help alleviate the situation.

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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. Stories are not inherently just.

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FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. This has been a decision we’ve been closely following.

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GeriPal

OCTOBER 24, 2024

This is back in, I don’t know, like 2014 maybe. Summary Transcript CME Summary Cannabis is complicated. It can mean many things, including a specific type of plant, the chemicals in the plant, synthetic analogs, or products that have these components. I am super excited to have you on, Eloise. Eloise 00:59 Thank you so much.

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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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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. Siddiqui October 31, 2023 Summary : This episode highlights the culture of food shaming and anti-fatness as it relates to anti-Blackness. During this episode, we hear from Da’Shaun L. Rebel Eaters Club.

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.

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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. Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is.

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GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC.

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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

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. It was refreshing to hear Scott and Kate express similar sentiments. Much more to come. And I get to play Phish, who Scott has seen about 100 times in concert. I saw them only twice.

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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? Given that there is no standard definition of race, its imprecision does not meet the standards of clinical medicine. How is race a social construct? Why was it constructed in the first place?

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GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. Is it you, Melissa? Melissa: It’s me.

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GeriPal

APRIL 6, 2023

Lexy: Yeah, so I can say that I became about, in 2014, I had the opportunity to lead a center at our health system called the Evans Center that focuses on religion, spirituality, and health. It meets in-person, once a month, over nine sessions. First, the lyrics, that’s the main reason why I chose it. The theme is death. LaVera: Yeah.

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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. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Pediatr Rev. Pediatrics.

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FDA Law Blog

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

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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. 2014 May;133(5):e1179-88. Cervical Spine Injuries are fortunately rare in children. Here is the aforementioned PECARN paper: Leonard, J.

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FDA Law Blog

APRIL 7, 2025

Zenrelia promotional materials also included claims about clinical data that the Agency found actionable. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Further, information presented on the adverse reaction data was inconsistent with the PI.

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