Whitepapers

How to Apply for an FDA Coronavirus Emergency Use Authorization Letter
Applying for a COVID-19 Emergency Use Authorization (EUA) Letter from FDA is no small feat, even though FDA has tried to simplify the process. We’ve worked directly with FDA on behalf of our clients (as authorized US agents) in order to address deficiencies or revise submissions based on evolving requirements.
Whitepaper May 27, 2020