FDA guidance
Annual Status Report Information and Other Submissions for Postmarketing Requirements and…
FDA guidance · Final · issued Sep 15, 2023
Key facts
| Title | Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Sep 15, 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 | Drugs |
| Docket number | FDA-2018-N-3771 |
| 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