FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Specific features of the PR will foreseeably yield new bases for challenge.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

DECEMBER 12, 2022

There appears to be significant overlap in content between the Checklist and informed consent forms and processes routinely provided by healthcare providers to their patients. FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval. In this context, this statement is absurd.

Manufacturing 52

Manufacturing Provider Patients IT 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. I’ve known Michele a long time, since the 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?

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

MAY 1, 2025

There was some at the time, which was 2006 so also, it’s been a while since the guidance has been updated and other guidance for other viral infections like hepatitis B and C. Eric 26:39 But I’m also hearing that 1 out of 10 newly diagnosed cases are not those individuals. Eric 18:33 Why did they do that?

Primary Care 94

Primary Care IT Provider Clinic 94