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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

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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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. According to the Medical Device Databases webpage, the De Novo database is to be updated weekly.

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Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

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.

Community 101
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Palliative care for cancer: Podcast with Jennifer Temel and Areej El-Jawahri

GeriPal

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. 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.

Illness 110
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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

Julianne: It’s interesting because I think I read somewhere that a finding in science often takes about, on average, 17 years to make it into medical practice. We’ll talk about is it in medical practice yet? She tried to extend conversations beyond what was medically, I think, necessary for the encounter.

IT 99
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Hospice in Prison Part 1: An interview with Michele DiTomas and Keith Knauf

GeriPal

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.

Families 132
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Understanding the Variability in Care of Nursing Home Residents with Advanced Dementia

GeriPal

On today’s podcast we dive into drivers of invasive procedures and hospitalizations in advanced dementia by talking to some pretty brilliant nursing and nurse practitioner researchers focused on dementia, geriatrics, and palliative care in nursing homes: Ruth Palan Lopez, Caroline Stephens, Joan Carpenter, and Lauren Hunt. Rehabbed to Death.