FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

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Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”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 Rescinded .

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FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. 25, 2014). When a Patient Speaks (Sept.

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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. But there are still a couple of possibilities lurking out there!

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Annals of Family Medicine

NOVEMBER 20, 2024

DDI exposures were considered incident if the individual was not exposed to a DDI in the year preceding cohort entry. Population: a 5% random sample of adult (19-64y) Quebec residents covered by the public drug insurance in 2014-2017 was used. 2) Hazard ratio for an adverse event (emergency room visit, hospitalization, or death).

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The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

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Doctor On Demand

APRIL 28, 2025

Here’s a closer look at the red-flag symptoms that signal it’s time to visit urgent care for a sore throat: Severe sore throat or trouble swallowing A severe sore throat or trouble swallowing suggests you might have a more complex underlying cause needing urgent medical attention. These symptoms require immediate medical attention.

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. AFP 2019 Gabapentin for chronic neuropathic pain in adults.

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GeriPal

JULY 21, 2022

Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. That’s where it really gets to this individual risks and balances, individual situation. They’re really not. Alex: Yeah.

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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. Available from: [link] Rice GM, Steiner RD.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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The Clinical Problem Solvers

NOVEMBER 16, 2020

Medicine has never been an apolitical field, and understanding the specific ways the medical field contributed to socio-political definitions of race through practices rooted in medical racism can help us avoid repeating the same harms of the past (e.g. 57:35 ​Conclusion and outro Episode Takeaways: History matters​. The New Press.

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GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). Alex: Coming up we talk with three pastoral care workers who are inmates who have been volunteering in the hospice at the California Medical Facility prison for some time. Alex: 2014.

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GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” I don’t see a lot of those out there.

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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. Nurse case management, social worker case management, medications, medical equipment, a home health aid, all that stuff goes away.

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GeriPal

APRIL 10, 2025

Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy? Eric 26:01 Curtis’s, he had a 2014 JAMA article on simulation. You’d have to tailor it to each individual emergency department because you couldn’t. So we know these patients are really, really sick.

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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. Elders Climate Action, and let me just tell you a little bit about who we are, was created in 2014 as the project of a 501(c)(3), Elders Action Network. Leslie: Well, yes, thank you, Ruth. Ruth: Right. Ruth: Yeah.

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BMJ

AUGUST 20, 2021

Increased health anxiety has been a feature of the pandemic, with fears around leaving the home, social distancing, hand hygiene, and shortages of goods and medications due to panic buying commonplace. Despite the spike in prescribing of insulins, oral antidiabetic medications were not similarly affected.

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FDA Law Blog

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 149, 158 (2014). Anthony List v. Driehaus , 573 U.S.

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