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Pediatric Drug Development


FDA Amendments Act of 2007 (FDAAA)

Best Pharmaceuticals for Children Act (BPCA)

  • Best Pharmaceuticals for Children Act, January 4, 2002 (Public Law No. 107-109). [HTML] [PDF]

BPCA/Pediatric Exclusivity

BPCA/Pediatric Exclusivity Statistics

Best Pharmaceuticals for Children Act of 2007 (BPCA of 2007)

FDAMA and Best Pharmaceuticals for Children Act of 2002

Written Request Templates

BPCA/Off-Patent Drugs

BPCA/Access to New Therapeutic Agents for Pediatric Cancer

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Pediatric Research Equity Act (PREA)

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Guidances for Industry

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  • 1994 Pediatric Final Rule: Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of "Pediatric Use" Subsection in the Labeling. (21 CFR Part 201)
  • Interim Rule: Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products [HTML][PDF]
  • 21 CFR 201.57 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs [HTML] [PDF]

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Pediatric Advisory Committee

Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee

FDA Pediatric Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee Meetings

Meetings of the Subcommittee

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Counter-Terrorism Measures for Use in Pediatrics

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Presentations by CDER Staff on Pediatric Issues

(Presentation slides do not provide complete information regarding labeling changes. For more complete labeling change information, including hyperlinks to the labeling of most products referenced in the presentation, please see: Pediatric Exclusivity Labeling Changes).








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The Division of Pediatric Drug Development (DPDD) is part of the Office of Counter-Terrorism and Pediatric Drug Development (OCTAP), in the Office of the Center Director, CDER.

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Historical References

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Other Resources

How to Contact Us

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Date created: March 19, 2003; Last updated: January 15, 2008

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