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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. But now we have older people dying of older people illnesses. There are clinics. He struggled with mental illness, substance use disorder. Michele: Yep.

Families 132

Families Family IT Community 132

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.

Primary Care 94

Primary Care IT Clinic Provider 94

Common Sense Family Doctor

MARCH 23, 2025

Despite this deliberately circumscribed mandate (I lost count of the number of times during my tenure as an AHRQ medical officer from 2006-2010 that I was told, "We don't make guidelines. You need not be ill enough to be hospitalized or care about practice guidelines to suffer if AHRQ is eliminated for good. Why do I care?

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52