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

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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CDOCS

APRIL 14, 2021

& Although the Redcam may have left a lot to be desired, my patients and I loved it.& <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.& & They, just like me, were engaged instantly by the technology.&

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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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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

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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GeriPal

DECEMBER 2, 2022

She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. When was that, 2010? Eric: 2010. You wrote about how when it comes to talking about patients with dementia, they’re rarely portrayed as resilient. I want to hug you.

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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

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

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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? Mike: Thanks for having me.

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GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? I moved to Baltimore in 2015 and did clinical fellowship in geriatrics. And then the second one in 2015.

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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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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

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. 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. And I had a blast playing Take the Money and Run!

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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

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. Eric: And what a research agenda that you’ve done, including one of the most seminal papers that we have in palliative care in lung cancer patients.

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GeriPal

JUNE 22, 2023

Healthcare staff were afraid of patients with HIV because there wasn’t clarity on how it was transmitted. 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.

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GeriPal

JUNE 5, 2025

Eric 03:25 So we have a lot to talk about, but I’m wondering if we can kind of take a big step back and just talk about the patient population that’s in nursing homes. Connie 06:18 So, I’ve been a clinician working in the nursing home since back in the 80s, and I saw a lot of patients that really needed palliative care.

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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. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Epub 2010 Oct 29.

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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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GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

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PEMBlog

MAY 9, 2024

Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. In a study from Kim published in Pediatrics in 2010, they looked at 526 children with complex febrile seizures.

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