. Author manuscript; available in PMC: 2009 Feb 1.

Published in final edited form as: Pediatr Clin North Am. 2008 Feb;55(1):187–xii. doi: 10.1016/j.pcl.2007.10.008

Table 5.

Milestones in Pediatric Drug Development

• 1977 — American Academy of Pediatrics Committee on Drugs - Report on study of drugs in children

• 1979 — FDA articulates how to provide information on Labeling

• 1997 — FDAMA/Exclusivity Provision

• 1998 — Pediatric Rule Regulation (enjoined 2002)

• 2001 — Subpart D regulations (adoption by FDA)

• 2002 — Best Pharmaceuticals for Children (BPCA)

• 2003 — Pediatric Research Equity (PREA)

• 2007 — BPCA and PREA sunset