Science & Research
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Scientific Activities and Statistics
Pediatric Science and Research Activities include work with our international colleagues, academia, NIH, WHO and professional and advocacy organizations. Efforts are directed towards analysis of submitted pediatric trials, identified ethical and safety issues, and publication and dissemination of data and results.
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Statistics
Written Requests Issued List of Determinations Including Written Request Pediatric Exclusivity Statistics Summaries of Medical and Clinical Pharmacology Reviews 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 Tracking Requirements Under FDAAA Breakdown of FDAAA Completed Pediatric Studies Pediatric Extrapolation Working Group Publications
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