# Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2000-10-06 · Effective 2000-10-06 · 65 FR 59718
## Document
- **Document number:** 00-25705
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 59718
- **CFR reference:** 21 CFR 601
- **Publication date:** 2000-10-06
- **Effective date:** 2000-10-06
- **HHS docket:** Docket No. 97N-0165
## Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently omitted. This action is being taken to improve the accuracy of the regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/10/06/00-25705/regulations-requiring-manufacturers-to-assess-the-safety-and-effectiveness-of-new-drugs-and)
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