Description
The draft guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These submissions and applications do not contain scientific data, or require regulatory review.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs | HTML | Open resource | |
| Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs | HTML | Open resource |