Description
This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance for market authorization requirements for COVID-19 drugs: Overview | HTML | Open resource | |
| Guidance for market authorization requirements for COVID-19 drugs: Overview | HTML | Open resource |