| Title | Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence |
| ToC Doc | Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence |
| Docket Number | 2023-20228 |
| Type | Notice |
| Subject | Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence |
| Publication Date | 2023-09-19 |
| Last Updated Date | 2023-09-18 08:15:10 -0400 |
| Last Public Inspection | 2023-09-18 |
| Filed At | 2023-09-18T08:45:00.000-04:00 |
| 2023-20228_PI.pdf (108088 bytes) | |
| Download | TXT / HTML / JSON |
| Number of Pages | 7 |
| Filing Type | regular |
| Agencies | Food and Drug Administration |
You can find the raw source document below...