FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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GeriPal

MAY 19, 2022

It depends on the clinical situation. But we still, regardless of how you do this calculation have to temper it with clinical judgment. Mary Lynn: I’m willing to bet that you temper that calculation with your clinical judgment though. Eric: All right. We want to switch from, let’s say morphine to Dilaudid.

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Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class.

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GeriPal

SEPTEMBER 7, 2023

Based on this surge in evidence, the American Society of Clinical Oncologists recently updated their guidelines for care of older adults to state that all older adults receiving systemic therapy (including chemo, immuno, targeted, hormonal therapy) should receive geriatric assessment guided care. Mazie, welcome to GeriPal. William: Sure.

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GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Eric 08:37 And that’s because you randomized clinics, you didn’t randomize patients interventions. We did it by the clinic level. And so everyone who’s in that clinic was.

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GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. It’s really special to be here and to be talking about this paper, which was really important to Randy. So what’s changed since 2018 with Jumpstart? Erin: Yeah, I can go first.

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GeriPal

APRIL 21, 2022

We talk not only about reading poetry, but also writing poetry, and using poetry in medical education as a healing modality. I think that in almost every clinical encounter, we struggle with what’s ours and what’s someone else’s? And along the way, we really felt like we got to the heart of things.

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Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. Among medical trainees suicide is the number one cause of death today.

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Physician's Weekly

JUNE 17, 2025

GLP-1 agonist medications Ozempic, Wegovy, and others also are delivering dramatic results for millions. For example, up to 15% of patients in the GLP-1 trials didn’t respond to those drugs, and at least one study found the medications didn’t significantly help Prader-Willi patients. Kennedy Jr.

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FDA Law Blog

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. However, TDD medications are highly concentrated opioids and cannot be self-administered. 2] Why is this an issue?

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PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay. And the clinical clues that a seizure has ended are often subtle. Pediatrics. doi: 10.1542/peds.2018-1009. PMID: 30297499.

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