1. Section 111 of Title I of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). http://www.fda.gov/cder/guidance/2891fnl.htm#ATTACHMENT%20A
2. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients (“Pediatric Rule”), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed. Reg. 66,632 (December 2, 1998).
3. Best Pharmaceuticals for Children Act. http://www.fda.gov/opacom/laws/pharmkids/pharmkids.html.
4. Pediatric Research Equity Act of 2003, http://www.fda.gov/cder/pediatric/S-650-PREA.pdf.
5. Report on the Experts’ Round Table on the Difficulties Related to the Use of New Medicinal Products in Children Held on 18 December 1997. http://www.emea.eu.int/pdfs/human/regaffair/2716498en.pdf