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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

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.

Manufacturing 52

Manufacturing Provider Patients Medical 52

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.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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.

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Family Families IT Community 132

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. I have 24,500 veterans on our caseload, 14,000 individuals with diagnosed mental health issue, 8,500 with an alcohol and substance abuse. Eric: And Susan?

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Community Nurse Practitioner Provider IT 89

GeriPal

MAY 1, 2025

Funding for research and clinical care is at risk, as USAID and PEPFAR (which is under USAID), are shuttered. And when she was here, she co founded the Golden Compass Clinic at San Francisco General Hospital for older adults living with HIV. The HIV clinics also served as primary care. Millions of lives are at stake.

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Primary Care IT Provider Clinic 94