FDA Guidance on the Q-Submission Program
Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!
FDA Guidance on the Q-Submission Program
A Summary of Risk Management Tools for Human Factors
Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021
FDA Final Rule on the Use of Symbols in Labeling
Updates from the FDA CDRH Human Factors Team 2019
Update on Hospital Access Challenges
FDA/CDER Workshop Highlights
FDA Draft Guidance - Comparative Use HF Studies in an ANDA