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2. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies;Roberts;JAMA,2003
3. Department of Health and Human Services. Code of Federal Regulations. Title 45, Part 46, Protection of Human Subjects, Subpart D.
4. Food and Drug Administration Code of Federal Regulations. Title 21, Part 50, Protection of Human Subjects, Subpart D.
5. How do institutional review boards apply the federal risk and benefit standards for pediatric research?;Shah;JAMA,2004