Paediatric Clinical Trials Guidance for Assessors
(2011; 41 pages)

Abstract

This guideline is intended for assessors in regulatory authorities who review protocols of clinical trials of medicines that involve children. The document is intended to complement existing guidance and documents (e.g. U.S. Food and Drug Administration, European Medicines Agency, etc.) on how to assess clinical trials protocols and will focus on paediatric-specific aspects only.

 
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