Office of Pediatric Therapeutics

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Ethics

• Subpart D--Additional Protections for Children Involved in Clinical Trials
• Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to Food and Drug Administration Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations

Pediatric Ethics Subcommittee

• Meetings
  • Pediatric Ethics Subcommittee meeting 6/9/08 and 6/10/08
• FDA Pediatric Working Group Consensus Statements based on the the Pediatric Advisory Subcommittee's meetings on the following dates:
  • April 24, 2001
  • September 11, 2000
  • November 15,1999
• Subpart D Working Group Members

Preamble & Guidance Documents

• Good Clinical Practice Program
• International Conference on Harmonisation
  • E11 Clinical Investigation of Medicinal Products in the Pediatric Population [PDF]

Pediatric Legislation

• Food and Drug Administration Amendments Act of 2007
• The Best Pharmaceuticals for Children Act [PDF]
• The Pediatric Research Equity Act [PDF]
• Pediatric Exclusivity
• Report to Congress 2001 [PDF]

BPCA Labeling Changes

PREA Labeling Changes

Safety Reporting

Pediatric Studies Summaries
(June 2003 – January 2008)

Pediatric Studies Full Review
(January 2008 – Present)

Written Request List
(2002 – 2007)

Written Request Documents (FDAAA)
(2007 – Present)

PREA Pediatric Study Data

Pediatric Advisory Committee (PAC)

• Charter
• Roster
• PAC Meetings -- 2008
  • 11/18/08: Adverse Event Reporting Update: Risperdal, Zyprexa, Levaquin, Lamictal, Ambien
    
  • 11/18/08: Adverse Report Reporting Update: Lamisil, Aldara, Sandostatin, Betopic S, Timolol GPS, Zyvox
    
  • 3/25/08: Adverse Report Reporting Update: Brevibloc, Lotensin, Trileptal
    
  • 3/25/08: Adverse Report Reporting Update: Toprol XL, Coreg, Colazal, Celebrex, Suprane, and Eloxatin
    
• PAC Meetings -- 2004-2007
  
• Meetings of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee -- 1999-2004

Parents and Children

• FDA Kids Page
• FirstGov for Kids
• Medicines in My Home
• Food Safety: For Kids, Teens & Educators
• Milk Matters for Kids
• healthfinder® Kids' Page
• NIDA for Teens: The Science Behind Drug Abuse
• BAM! Body and Mind
• Girl Power!
• GirlsHealth.gov

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FDA Office of Pediatric Therapeutics