FDA Law Blog

FEBRUARY 9, 2024

Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. investigational device as defined in 21 C.F.R. Part 812, the requirements under 21 C.F.R.

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

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. Communication techniques we can use when talking to individuals with hearing loss. Think about the last time you attended a talk on communication skills or goals of care discussions.

IT 102

IT Screening Hospital Clinic 102