1. Best Pharmaceuticals for Children Act. Public Law 107-109. In: 115 Stat. 107th Congress. 2002:1408–1424.
2. Pediatric Research Equity Act of 2003. Public Law 108-155. In: 117 Stat. 108th Congress. 2003:1936–1943.
3. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA2003;290(7): 905–911.
4. National Institutes of Health. NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. March 6, 1998.
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
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5. Food and Drug Administration. 21 CFR Parts 50 and 56: Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products. Federal Register 2001;66(79):20589–20600.