FDA guidance
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food…
FDA guidance · Final · issued Oct 8, 2015
Key facts
| Title | Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act |
|---|---|
| Status | Final |
| Issue date | Oct 8, 2015 |
| 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-2014-D-2138 |
| Comments close | May 17, 2015 |
| 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