FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). The rule became final on October 5, 2021 via publication in the Federal Register. The new rule will be codified in 21 C.F.R. Part 860. Part 807, Subpart E) and the PMA regulations (21 C.F.R.

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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

NOVEMBER 20, 2024

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

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FDA Law Blog

FEBRUARY 27, 2023

While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others.

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

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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: But is that just something special about methadone and buprenorphine?

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Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine. ” In 27 states and Washington, D.C.,

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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. She also serves as Pillar Co-Lead for Community Engagement at NYU Langone’s Institute for Excellence in Health Equity.

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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

I think that in almost every clinical encounter, we struggle with what’s ours and what’s someone else’s? I think that we forget that the clinical encounter is very often just two people in a room experiencing each other, and that that’s what is the beginning of that sacred space of healthcare and healing.”

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Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. I was in a big-box clinic. Does that make any sense at all?

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Physician's Weekly

JUNE 17, 2025

Since the drug trial started in 2018, some of her adult patients have begun living independently, getting into college, and starting jobs — milestones that once felt impossible. Dean attends a special education program, his mother said. She said the impact she’s seen is life-changing. That future may already be taking shape.

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FDA Law Blog

JUNE 23, 2024

However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes. 2] Why is this an issue?

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PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Well, they say that LP should be performed when there are meningeal signs or symptoms or other clinical features that suggest possible meningitis or intracranial infection. And the clinical clues that a seizure has ended are often subtle. Pediatrics. doi: 10.1542/peds.2018-1009.

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