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.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

DECEMBER 12, 2022

In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. This document is intended only to provide clarity to the public regarding existing requirements under the law.”

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. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.

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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. It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Eric: And Susan?

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Community Nurse Practitioner Provider IT 89

GeriPal

MAY 1, 2025

Have been now a care provider for people with HIV for over 40 years. And I became more and more involved in it, including becoming involved in research and developing some of the programs initially to provide care for people with both drug use and HIV related problems, women with HIV vulnerable populations. I don’t know exactly.

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Primary Care IT Provider Clinic 94