Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
other · Food and Drug Administration · Rule · Published 2013-02-26 · Effective 2013-03-28 · 78 FR 12937
Document
Document number
2013-04387
Federal Register citation
78 FR 12937
CFR reference
21 CFR 50
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-02-26
Effective date
2013-03-28
HHS docket
Docket No. FDA-2000-N-0009
Abstract
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.