FDA Law Blog

OCTOBER 14, 2024

2014); U.S. The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d 3d 1302 (11th Cir.

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Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”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

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. Sorenson follows the Fifth Circuits decision last year in United States v. Medicare or Medicaid). In contrast to its decision in United States v.

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FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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FDA Law Blog

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE Consequently, because both applications were approved at the same time, both applications represent the first permitted commercial marketing or use of the product or the individual active ingredients, as outlined under 35 U.S.C. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. §

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Pamela Wible MD

JUNE 20, 2025

Psychiatrists define burnout as a job-related dysphoria in an individual without major psychopathy—meaning you’re normal; your job is killing you. It’s a growing crisis affecting over half of all doctors in the U.S., and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.

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FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.

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The Clinical Problem Solvers

MARCH 4, 2024

She discovered narrative medicine, and to her, it was about finding and retelling individual and structural stories in antiracist ways. Listening to individual stories within the context of their structural stories is important. Sayantani became a physician since she thought it was a concrete tool for social justice.

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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

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. Eric: What’s the song? Emmy: I just forgot the name of the song… [laughter]. Alex: Pink Cadillac by Bruce Springsteen? I like that song.

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Doctor On Demand

APRIL 28, 2025

Listen to a discussion on getting help for a sore throat When to go to urgent care for a sore throat Go to urgent care if your sore throat is severe, lasts more than five days or comes with other symptoms like a high fever, swollen lymph nodes, or you have difficulty swallowing. This is a medical emergency where you should call 911.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes palliative care for people experiencing homelessness challenging? What makes it rewarding? those experiencing homelessness).

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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. References Jeanmonod R, Asuka E, Jeanmonod D.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. 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. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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GeriPal

AUGUST 25, 2022

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. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa?

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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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GeriPal

JUNE 29, 2023

He taught us a little about the different flowers and plants, and along the way a little about why he does what he does. One story that Allan told perfectly sums this up. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. So take a listen.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

This is done on an individual level, by offering existing support and resources, as well as on a systemic level through advocacy. [link] This is the first episode of a three-part series on understanding and dismantling race-based medicine by unearthing its origin and exposing the paucity of rigorous evidence in support of it. For genetics?

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FDA Law Blog

SEPTEMBER 6, 2021

Briefly (more detail is available here ), GSK sued Teva back in 2014 alleging that Teva induced infringement of a method-of-use patent when Teva marketed a skinny-labeled generic version of GSK’s Coreg (carvedilol) as AB-rated. Teva decision changed everything.

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GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.

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BMJ

JUNE 25, 2021

The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. 6–8 Instead, observational studies could contribute to statin research by assessing the effects of prolonged exposure. and the prediction window at 5 years. Eur Heart J.

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BMJ

AUGUST 20, 2021

We sought to analyse how prescribing trends have changed over time, utilising a dataset containing all prescriptions signed and dispensed in the UK by primary care facilities from January 2014 to November 2020.

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FDA Law Blog

MAY 26, 2025

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. 149, 158 (2014). Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. MedImmune, Inc.

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