FDA guidance
Analytical Procedures and Methods Validation for Drugs and Biologics
FDA guidance · Final · issued Jul 27, 2015
Key facts
| Title | Analytical Procedures and Methods Validation for Drugs and Biologics |
|---|---|
| Status | Final |
| Issue date | Jul 27, 2015 |
| 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 | Drugs |
| Docket number | FDA-2015-N-0007 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- 1–9 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