Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products

The Food and Drug Administration (FDA) is issuing an interim rule to amend its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This interim rule is intended to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act), which requires that within 6 months of its enactment 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. To comply with this congressionally mandated timeframe and for other reasons described in this document, FDA is publishing this regulation as an interim rule. FDA is requiring additional safeguards to protect children because of expected increases in the enrollment of children in clinical investigations as a result of recent pediatric initiatives. These initiatives include FDA's 1998 pediatric rule (the 1998 pediatric rule) and the pediatric provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).