Pediatric medicinal product research and development

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In Folder: 2012 Theses

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Pediatric medicinal product research and development

title: Pediatric medicinal product research and development : issues, challenges and proposals for improvement.

creator: Hittinger, Tara

subject: Pediatric pharmacology

subject: Food and Drug Administration

subject: Pharmaceutical policy

department: Regulatory Affairs, Pharmac. Eco., Health Policy

program: Thesis (M.S.)

abstract: The objectives of this study were to analyze and compare the pediatric regulations of the United State Food and Drug Administration (FDA) and the centralized approval procedures of the European Union European Medicines Agency (EMA). The comparison included requirements, rewards and incentives, and committees related to pediatric MP development.

date: 2012-04-30

type: Thesis/Dissertation

rights: Author owns copyright

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