FDA guidance
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff
FDA guidance · Draft · issued Dec 12, 2018
Key facts
| Title | Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff |
|---|---|
| Status | Draft |
| Issue date | Dec 12, 2018 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Drugs |
| Docket number | FDA-2018-D-4267 |
| Comments close | Feb 11, 2019 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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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