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Pediatric Exclusivity (PDE)
Pediatric Exclusivity (PDE)
Under Section 505A of the Food, Drug, and Cosmetic Act (FD&C), the FDA can issue written requests for paediatric studies if it agrees that a drug’s paediatric use may produce health benefits. As an incentive to conduct these studies, §505(A) offers six months of marketing exclusivity, “Paediatric Exclusivity.”