FDA guidance
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
FDA guidance · Final · issued May 26, 2023
Key facts
| Title | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products |
|---|---|
| Status | Final |
| Issue date | May 26, 2023 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs |
| Docket number | FDA-2019-D-0934 |
| 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