FDA Law

SEPTEMBER 30, 2022

Billy Dunn, the Director of CDER’s Office of Neuroscience, at the September 7, 2022 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, applying the statutory standard in approval decisions in these clinical contexts warrants the “broadest possible” flexibility. By Frank J. Sasinowski & James E.

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FDA Law

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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CDOCS

APRIL 14, 2021

<br /> <br /> In 2010, I upgraded to the Bluecam and also added the necessary armamentarium to be able to produce e.max restorations in office.& & & The 4-Y structure provides 1000 mPa in flexural strength, but also allows me to deliver a restoration that I am happy to see on recall.&

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FDA Law

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.

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FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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GeriPal

DECEMBER 2, 2022

When was that, 2010? Eric: 2010. Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here.

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Community IT Individual Patient-Centered 101

FDA Law

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. Each of these De Novos can represent a clinical advance. These legislative changes helped.

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Specialization Hospital Physicals Provider 69

FDA Law

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

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.

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Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. And then in 2010, the AGS took over because it was sort of wafting out there and people were wondering, when are you going to update it? We’ll learn about that.

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Medical IT Patients Clinic 97

GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers. Welcome back, Ashwin. Alex: Great.

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IT Community Patient-Centered Medical 99

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Lynn: Okay.

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IT Patient-Centered Illness Education 126

FDA Law

OCTOBER 24, 2024

By 2010, about 2000 isolated human genes had been patented in the U.S. In 2010, the Association for Molecular Pathology (AMP), among other organizations, brought suit against Myriad Genetics, challenging the validity of the company’s patents on the BRCA 1/2 genes. animal, viral, bacterial) DNA and RNA sequences. Supporters of AMP v.

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Manufacturing Clinic IT Vaccination 64

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. For healthcare providers, there should be a recognition that holistic care involves more than just prescribing medications.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. That trajectory was in increase from 2000 to say, 2010. Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. But before we do, I think somebody has a song request.

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Families Family IT Patients 106

GeriPal

JUNE 5, 2025

Cari 01:42 I would like to request Hallelujah, one of my favorite songs. And I love hearing you sing, and so it’s an excuse to have you sing a beautiful song. And it’s, I think, a very uplifting song. And I’m so pleased with Connie and that she’s doing so well, and so it’s a celebration of her, too. No problem.

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GeriPal

JUNE 22, 2023

Today’s podcast is part one of a two-part podcast where we spend a day at CMF, a medium security prison located about halfway between San Francisco and Sacramento, and the hospice unit housed inside its walls. Afterwards, we chat with the prison’s chaplain, Keith Knauf. And it’s an incredibly compelling place to work. Eric: Yeah. Alex: Yeah.

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GeriPal

JULY 28, 2022

Jennifer’s study is most widely known for the “kicker” – not only did it improve quality of life, palliative care was associated with a couple months longer survival. . Areej’s study is remarkably novel in that it is, to our knowledge, the first study of palliative care during curative treatment. . Alex: (singing). Areej: Wow.

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PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Epub 2010 Oct 29. Cervical Spine Injuries are fortunately rare in children. Here is the aforementioned PECARN paper: Leonard, J. 2010.08.038.

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Patient-Centered Patients IT Hospital 52

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. Archives of Internal Medicine 2010. The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Rehabbed to Death. Welcome to the GeriPal Podcast, Caroline. Caroline: Thanks, Alex. Thanks, Alex.

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Nurse Practitioner Hospital Families Family 60

GeriPal

MARCH 20, 2025

And is there a middle path to provide some degree of comfort while also hastening the end of life? I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. Should these patients qualify for medical aid in dying medications? Eric 00:13 And Alex, who do you have with us today?

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IT Patient-Centered Patients Medical 88

GeriPal

SEPTEMBER 19, 2024

Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Give too little – it may not work. But before we jump into that topic, Jennifer, do you have a song request for Alex? Jennifer 01:20 I do have a song request for Alex. Saw them play a couple times.

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Patient-Centered IT Patients Hospital 119

PEMBlog

MAY 9, 2024

This episode is all about febrile seizures, one of the most common neurological problems that you will see in the emergency department in children. And you know what? I’m going to structure this episode like a bit of a question and answer session. I’ll ask a question, and then I’ll answer it. And why does the complex heterogeneity?

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