Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy (English, HTML)
View metadata and access the original English HTML file: Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy.
- Format
- HTML
- Access
- file-only
- Publisher-reported update
- 2023-09-30
The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.
Data overview
- Formats
- HTML
- File languages
- English
- Available actions
- Access original file