1. Anonymous (1997): Pediatric Patients: Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products: proposed rule. 21 CFR Parts 201, 312, 314, and 601.
2. Anonymous (1994): Specific requirements on content and format of labeling for human prescription drugs; Revision of ‘pediatric use’ subsection in the labeling; Final rule. US Federal Register 59(238): 64240–64250.
3. Anonymous (1995): Section 505 (b) of the Federal Food, Drug and Cosmetic Act 21 USC 321 et seq. pp.505 (b) USC 321.
4. Unapproved uses of approved drugs;Pediatrics,1996
5. Department of Health and Human Services (2000): U.S. Public Health Service, Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda, Washington, DC.