Lavanya Rajamanickam
Lavanya Rajamanickam, Department of Pharmaceutical Regulatory Affairs, Acharya & BM Reddy College of Pharmacy, Bengaluru, Karnataka, India
JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.