Pediatric Exclusivity Studies' "Extrapolatability" Focus Of Injunction Hearing
This article was originally published in The Tan Sheet
Executive Summary
Pediatric provisions in the FDA Modernization Act do not mandate that pediatric studies have to be "extrapolatable" from specific drug products to other products in the line containing the same active moiety, D.C. federal court Judge James Robertson indicated at an April 9 hearing.
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