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. This comparison is misplaced.
FDA Law Blog
DECEMBER 12, 2022
This form lists important risks, including those known or reported to be associated with the use of the LASIK laser devices based on information from clinical trials, scientific literature, and reports from patients who have undergone LASIK. After reviewing the information. please read and discuss the items in this checklist with your doctor.
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Permanente Medicine
APRIL 29, 2025
million men and women aged 50 to 75 examined the outcomes of a Kaiser Permanente Northern California initiative begun in 2006 to increase colorectal cancer screening rates. Findings from the study demonstrate how routine cancer screening with a test that can both prevent cancer and lead to earlier detection helps enhance quality of care.
FDA Law Blog
MARCH 15, 2023
See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.
GeriPal
MARCH 2, 2023
2006 Transcript Eric: Welcome to the GeriPal Podcast. And so it pops up and if you’re a different prescriber from a different healthcare system, you can still see if people have filled it, it’s limited to the amount of fills you can get in the amount of tablets or capsules you can get in a month. Annals of IM. Tasce: Right.
GeriPal
JUNE 22, 2023
We start off part one by interviewing Michele DiTomas, who has been the longstanding Medical Director of the Hospice unit and currently is also the Chief Medical Executive for the Palliative care Initiative with the California Correctional Healthcare Services. There are clinics. Shout out to the UC Berkeley-USCF Joint Medical Program.
GeriPal
JULY 6, 2023
Started as a direct case manager, worked in a variety of different places including the state legislature and I’ve been with the state office now since 2006. There’s so many great tech tools out there now that older adults are using and can use to really wrap around the social services and the clinical services.
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