Source: Regxia Blog

Regxia Blog FDA Draft Guidance - General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products

On December 08, 2014 US Food and Drugs Administration (FDA) issued draft guidance for industry entitled "General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products." This guidance provides recommendations to sponsors on how to conduct pediatrics studies ... Continue reading →

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Betty A. Cory's photo - President of Regxia

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