Louisville Lectures

MAY 25, 2018

After, he reviews elements of the chest physical exam and finally, he reviews the fundamentals of clinical reasoning concerning chest pain. He served as an Assistant Professor at Loyola University while completing his MD at Rush Medical College in Chicago, IL, where he graduated in 2014.

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Internal Medicine Physicals Medical Clinic 52

The Clinical Problem Solvers

JUNE 12, 2022

Clinical Reasoning Corner: Problem Representation By: Marcela A. de Oliveira Santana and Franco Murillo Reviewed by: Jack Penner Welcome back, Clinical Problem Solvers! The problem representation during the clinical reasoning process The PR is linked to hypothesis-generation and can act as a guide during the diagnostic journey.

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PEMBlog

OCTOBER 11, 2023

Clinical signs of bladder injury are nonspecific. 2014 Aug;192(2):327-35. Epub 2014 May 20. Additionally, when the bladder is full, it can ascend into the abdomen, rendering it more susceptible to damage from blunt forces. To diagnose bladder rupture, CT cystography is the preferred diagnostic test. Urotrauma: AUA guideline.

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The Direct Doctors Difference

AUGUST 18, 2021

According to DPC Frontier, a site owned by a DPC physician/lawyer who was a founder of the movement, there are now over 1500 clinics doing pure Direct Care across the nation. Looking back to 2014, when we began, there were less than 100. There are likely many more than have been officially labeled on the map.

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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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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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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.

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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. References Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O’Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. N Engl J Med. doi: 10.1056/NEJMoa1802598. PMID: 30462938; PMCID: PMC6358014.

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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. FDA’s position is, however, only one side of the story.

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FDA Law Blog

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. Certain factors may require some confirmatory studies to be more underway than others. rare disease settings).

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The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. The Clinical Problem Solvers Podcast. Racism hurts all people and achieving anti-racism will require active “fellows in the struggle” not just feeling allies. References Mentioned 01:55 Jones, C. Camara Jones, Allegories on race and racism | Camara Jones | TEDxEmory. Accessed January 11, 2021. 03:55 Jones, C.

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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.” randomization, blinding).” Granted .

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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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Clinic IT Provider Patient-Centered 59

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

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 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

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. See our memo summarizing CMS’s regulation here. All of these products are line extensions under CMS’s definition.

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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

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.

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FDA Law Blog

DECEMBER 11, 2023

2, 2014), [link]. [12] Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology, toxicology, hematology, and molecular genetics. [15] FDA, Transcript of CDRH Webinar regarding Proposed Rule: Medical Devices; Laboratory Developed Tests, at 9-10 (Oct. 31, 2023), [link]. [10] 11] Jeffrey N.

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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. 8) VisualDx Thousands of hospitals, clinics, and medical schools use VisualDx to aid diagnostic accuracy, enhance medical education, and improve patient outcomes.

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Physician's Weekly

JUNE 21, 2025

Screening was done using predefined criteria, and 2 researchers independently extracted the data.

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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. 2014 Feb;103:126-133.

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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.

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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. Anti-Blackness, Anti-Fatness, and Food Shaming” The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. is rooted in anti-Blackness. November 7, 2023.

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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. Is my sore throat contagious?

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GeriPal

OCTOBER 24, 2024

This is back in, I don’t know, like 2014 maybe. And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. I’d been a nurse at the time, and I went back to do my clinicals in an oncology clinic locally. Eric, do you want me to go first?

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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

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. And then we had clinical decision support. What is a clinical decision support? Long overdue.

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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. The Clinical Problem Solvers Podcast.​ ​[link] November 17, 2020. The New Press.

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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

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

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. Eric: Let’s say I have a panel of older adults that I’m seeing, or a palliative care outpatient clinic. Love to talk about also in the serious illness population. I’ll just say that.

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