FDA Law Blog

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. 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.

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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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GeriPal

DECEMBER 2, 2022

When was that, 2010? Eric: 2010. And for people with dementia and their caregivers, who both feel very devalued in the social system, support systems, their communities, the medical system. Somehow or other he talked this medical system into allowing him to develop the Alzheimer’s Center of Excellence.

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GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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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). Objective: To determine whether resident-facility language concordance/discordance is associated with the odds of potentially inappropriate prescribing of antipsychotics (PIP-AP) in LTC.

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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. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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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. Eric: You’ve timed it perfectly.

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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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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 22, 2023

Summary Transcript Summary In the early 1990’s, California Medical Facility (CMF) created one of the nation’s first licensed hospice units inside a prison. Alex: We are in the California Medical Facility and we will ask our guest about that. I’ve known Michele a long time, since the Joint Medical Program. Michele: Yep.

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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. And assisted living doesn’t offer the same level of medical supportive services as nursing homes. So the palliative care service doesn’t necessarily need to provide those potentially. Alex actually was a. I think senior author.

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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

JULY 28, 2022

And so I went into medical school wanting to cure cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. Jennifer: It was 2010.

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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

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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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

Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay. 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.

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