1. Specific requirements on content and format of labeling for human prescription drugs; Revision of Pediatric Use’ subsection in the labeling; Final rule;Federal Register,1994
2. Pediatric Patients; Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New Drugs and Biological Products; Final Rule;Federal Register,1998
3. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077853.pdf
4. www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf