Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition‪)‬

The Law Library presents the complete text of the Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

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.

This ebook contains:
- The complete text of the Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure