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Drugs
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Resources for You
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Pediatric Drug Development
Many of FDA's initiatives around pediatrics have aimed to improve medical product research in children. This is making for safer and more effective treatments.
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FDA Amendments Act of 2007 (FDAAA)
- FDAAA - Title IV: Pediatric Research Equity Act of 2007 (PREA) and Title V: Best (PDF - 383KB)
- Internal Review Committee - Memorandum Establishing Pediatric Review Committee (PDF - 257KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
- Pediatric Labeling Table (PDF - 660KB)
New Pediatric Information in Labeling - FDAAA Pediatric Studies Characteristics
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Best Pharmaceuticals for Children Act (BPCA)
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BPCA/Pediatric Exclusivity
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FDAMA and Best Pharmaceuticals for Children Act of 2002
- Breakdown of Requested Studies Report
- Written Requests Issued
- Pediatric Exclusivity Granted
- Pediatric Exclusivity Statistics
- Spectrum of Diseases/Conditions
- Summaries of Medical and Clinical Pharmacology Reviews
- Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
- Written Request Templates
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BPCA/Off-Patent Drugs
- Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 9/18/2007)
- List of Drugs for Which Pediatric Studies are Needed
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BPCA/Access to New Therapeutic Agents for Pediatric Cancer
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Pediatric Research Equity Act (PREA)
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FDA Pediatric Ethics Working Group Consensus Statement on Pediatric Advisory Subcommittee Meetings
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Historical References
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