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.
FDA Law Blog
AUGUST 18, 2024
Each of these De Novos can represent a clinical advance. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. De Novos now play an important role in product advancement. For example, FDA granted seven De Novos for COVID-19 related indications for use.
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Annals of Family Medicine
NOVEMBER 20, 2024
Context Individual, social, and built environments interact to shape physical activity (PA), with responses to environmental cues often differing by gender. Light physical activity (LPA) is infrequently studied, yet may be particularly sensitive to such influences. PA was measured using accelerometers.
GeriPal
DECEMBER 2, 2022
When was that, 2010? Eric: 2010. I started out working on a grant in a NeuroPAL clinic with people that had advanced Parkinson’s and related disorders and Alzheimer’s. The programming in nursing homes, one of the things that has to change is that it has to be integrated into the clinical, it can’t be separate.
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.
GeriPal
JULY 28, 2022
And as a resident, I just was drawn, similar to many oncology clinicians and fellows, to just be traumatic and difficult experience of patients with blood cancers during prolonged and intense hospitalizations, where they experience a lot of physical symptoms, emotional trauma related to the diagnoses. Jennifer: It was 2010. Eric: 2010.
GeriPal
FEBRUARY 29, 2024
But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. Anne: Which episode of the GeriPal podcast has most significantly changed your clinical practice? We mentioned her name before.
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