FDA guidance
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug…
FDA guidance · Draft · issued Mar 13, 2024
Key facts
| Title | Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products |
|---|---|
| Status | Draft |
| Issue date | Mar 13, 2024 |
| 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-2023-D-5616 |
| Comments close | May 13, 2024 |
| 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