FDA guidance
Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance…
FDA guidance · Draft · issued Aug 19, 2025
Key facts
| Title | Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for Industry |
|---|---|
| Status | Draft |
| Issue date | Aug 19, 2025 |
| Center | Office of the Commissioner |
| Issuing office | Oncology Center of Excellence |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs |
| Docket number | FDA-2024-D-5850 |
| Comments close | Oct 20, 2025 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents