# Safety Reporting Requirements Human Drug/Biological Products

> **FDA** · Rulemaking · Modified 2026-03-17T12:00:53Z

## Docket
- **Docket ID:** FDA-2000-N-0108
- **Agency:** FDA
- **Type:** Rulemaking
- **Last modified:** 2026-03-17T12:00:53Z

## Source
- [regulations.gov docket](https://www.regulations.gov/docket/FDA-2000-N-0108)
- [Public comments](https://www.regulations.gov/docket/FDA-2000-N-0108/comments)

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