Description
The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy | HTML | Open resource | |
| Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy | HTML | Open resource |