FDA Law Blog

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. emphasis added).

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FDA Law Blog

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

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FDA Law Blog

SEPTEMBER 11, 2023

Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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FDA Law Blog

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. FDA’s position is, however, only one side of the story.

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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 Blog

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.

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FDA Law Blog

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. FDA thus disagrees that such differences are not clinically meaningful. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA.

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FDA Law Blog

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 Blog

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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GeriPal

DECEMBER 2, 2022

When was that, 2010? Eric: 2010. This whole conference that Ab puts on, and all of the tools and resources that he provides people and families with dementia are about, how do you build on the remaining strengths? It has to be seen as valued to clinical outcomes. And it has to be reimbursable.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). Using linked administrative databases, we identified all instances of PIP-AP according to the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as ED visits and hospitalizations.

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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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FDA Law Blog

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. HPM is currently representing AMP in unrelated litigation.)

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Manufacturing Clinic IT Vaccination 64

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? Mike: Thanks for having me.

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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. And then the second one in 2015.

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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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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.

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GeriPal

JUNE 5, 2025

Nursing home, length of stay, I think it was like back in 2010, at the end of life. So usually they’ll make recommendations, maybe some medication adjustments or something like that, and then the provider that’s caring for them in house will take over from there. Alex actually was a. I think senior author. Eric 13:49 Right.

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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. I do think the growth of for-profit hospice, so around 2000 to 2010, was beneficial in terms of access. People with dementia make up about half of hospice admissions.

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GeriPal

JUNE 22, 2023

And that grew into a group of volunteers coming back and at least providing support groups, giving those men a place where they could talk at least. So in 2010, there were about 150,000 incarcerated people in California. They didn’t have a mentor, a financial provider, all of those things. There are clinics.

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GeriPal

JULY 28, 2022

And so often, these patients experience a lot of hospitalizations, numerous hospitalizations while they receive intensive chemotherapy that requires prolonged periods of neutropenia and toxicities, or stem cell transplantation, which is what I specialize in clinically now. Jennifer: It was 2010. Eric: 2010. Jennifer: Yeah.

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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. I was really struck by the difference in care provided to people with advanced dementia. Ruth: Sure.

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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. If they have no pain in the midline with any of these movements, then the cervical spine is clinically cleared.

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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. And then finally you have the moral distress of the providers. Why did you write this paper? Well, how can I be.

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GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? Chris 07:41 Yeah, it’s a really interesting thing, because the 2010 article was solving the problem of, hey, send us patients, we promise we won’t kill them. Eric 07:25 I guess, Chris, from your perspective.

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PEMBlog

MAY 9, 2024

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. In a study from Kim published in Pediatrics in 2010, they looked at 526 children with complex febrile seizures. So what does the AAP say? You can do this.

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