FDA Regulation of Pediatric Drugs Quiz

• The Pediatric Research Equity Act of 2003
• The Best Pharmaceuticals for Children Act of 2002 (correct)
• The FDA Modernization Act of 1997
• The FDA regulation issued in December 1998

• The FDA to regulate pediatric drugs more strictly.
• Pharmaceutical industries to conduct and submit pediatric clinical trials.
• Drugs used in pediatrics require literature or clinical trials supporting their use, even if the original patent did not have a pediatric indication. (correct)
• Manufacturers to provide additional information about the use of their drug products in pediatric patients.

• 2003
• 1997
• December 1998 (correct)
• 2002