Drugs
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Pediatric Product 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.
For further information about pediatric product development, please contact pedsdrugs@fda.hhs.gov or 301-796-0700.
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FDA Safety and Innovation Act (FDASIA)
- FDA Safety and Innovation Act
See Title V for pediatric drugs and devices.
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FDA Amendments Act of 2007 (FDAAA)
- Full-text of Pediatric Research Equity Act of 2007 (PREA) (PDF - 383KB)
See Title IV. - Full-text of Best Pharmaceuticals for Children Act of 2007 (BPCA) (PDF - 383KB)
See Title V. Pediatric Tracking Requirements Under FDAAA Internal Review Committee - Memorandum Establishing Pediatric Review Committee (PDF - 257KB)
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Best Pharmaceuticals for Children Act (BPCA)
- 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)
(Pediatric study of off-patent drugs under BPCA) - List of Drugs for Which Pediatric Studies Are Needed
(Pediatric study of off-patent drugs under BPCA) Patient Access to New Therapeutic Agents for Pediatric Cancer, December 2003: Report to Congress. (PDF - 183KB)- Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57KB)
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Pediatric Research Equity Act (PREA)
PREA Retrospective Review (PDF - 281KB)
1/14/2010- Pediatric Research Equity Act of 2003 (Public Law No: 108-155) (posted 12/16/2003) (PDF - 50KB)
Guidance for Industry (Draft): How to Comply with the Pediatric Research Equity Act (posted 9/7/2005) (PDF - 116KB)- Postmarket Requirements and Commitments Database
To view PREA postmarket requirements, check the Pediatric Research Equity Act box in the 'Required Under' section.
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Pediatric Formulations Developed to Earn Pediatric Exclusivity But Not Marketed
Formulations Not Marketed (PDF - 19KB)
Posted 4/19/2010
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Pediatric Statistics - Written Requests
Written Requests Issued
A list of approved active moieties and the sponsor to whom the written request was issuedPediatric Exclusivity Granted
A list of active moieties granted pediatric exclusivity and indications studiedList of Determinations Including Written Request
Pediatric exclusivity determinations including written requestsWritten Request Template
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Pediatric Statistics - Other
Breakdown of FDAAA Completed Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA) - Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2007 (FDAAA)
New Pediatric Information in Labeling - Searchable (PDF - 16KB)Pediatric Exclusivity Statistics Pediatric Study Characteristics - Searchable (PDF - 16KB)Spectrum of Diseases/Conditions Summaries of Medical and Clinical Pharmacology Reviews
This statistic has not been updated since 1/2008 because the law changed and now requires that full reviews be posted.
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