FDA Regulation of Pediatric Drugs Quiz
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Questions and Answers

Which Act provided support for pharmaceutical industries to conduct and submit pediatric clinical trials?

  • 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

    • What did the Pediatric Research Equity Act of 2003 mandate?

  • 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.

    • When was the FDA regulation issued that required manufacturers to provide additional information about the use of their drug products in pediatric patients?

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

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