Description
Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance on applications for drug clinical trials under the interim order: Additional requirements | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Application guidelines and process | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Who to contact | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Overview | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Post-authorization requirements | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: General requirements | HTML | Open resource | |
| Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: General requirements | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Additional requirements | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Overview | HTML | Open resource | |
| Guidance on applications for drug clinical trials under the interim order: Post-authorization requirements | HTML | Open resource |