FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

Clinic 105

Clinic Manufacturing Provider Electronics 105

FDA Law Blog

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

Manufacturing 52

Manufacturing Clinic Engineering Individual 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? 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. I’m guessing not. How to screen for hearing loss. Transcript.

IT 102

IT Screening Hospital Clinic 102