FDA guidance
E19 OPTIMISATION OF SAFETY DATA COLLECTION
FDA guidance · Draft · issued Jun 27, 2019
Key facts
| Title | E19 OPTIMISATION OF SAFETY DATA COLLECTION |
|---|---|
| Status | Draft |
| Issue date | Jun 27, 2019 |
| 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-2019-D-1828 |
| Comments close | Aug 26, 2019 |
| 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