FDA guidance
Benefit-Risk Assessment for New Drug and Biological Products
FDA guidance · Final · issued Oct 17, 2023
Key facts
| Title | Benefit-Risk Assessment for New Drug and Biological Products |
|---|---|
| Status | Final |
| Issue date | Oct 17, 2023 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs |
| Docket number | FDA-2020-D-2316 |
| 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