1. Wells TG. Underserved therapeutic classes: examples which should not be ignored in infants and children. Drug Inf J 1996; 30: 1179–1186.
2. Specific requirements on content and format of labeling for human prescription drugs; revision of “Pediatric Use” subsection in the labeling; final rule. Food and Drug Administration, Department of Health and Human Services. Federal Register 1994;59:64240–64250, December 13, 1994.
3. Food and Drug Administration, Department of Health and Human Services. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologic products in pediatric patients; final rule. Federal Register 1998;63:66631–66672, December 2, 1998.
4. Food and Drug Administration Modernization Act of 1997. Public Law 105–115, 1997.
5. Best Pharmaceuticals for Children Act. Public Law 107–001, 2002.