Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment
other · Food and Drug Administration · Rule · Published 2000-10-06 · Effective 2000-10-06 · 65 FR 59718
Document
Document number
00-25705
Federal Register citation
65 FR 59718
CFR reference
21 CFR 601
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
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.