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

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And one of the parts of that was actually doing physicals for the students and putting them in job placements.

IT 102

IT Screening Hospital Clinic 102

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We’re going to be talking about new research in psilocybin in serious illness. This is Eric Widera. Alex 00:03 This is Alex Smith. Thats a lot of S s.

Illness 107

Illness IT Patient-Centered Patients 107