Sample Case #3

• Q. A sponsor submits an application for an NDA to the FDA for an indication that the reviewing division determines does not exist in children. The reviewing division grants the sponsor a waiver from the pediatric requirement of the 1998 Rule. The sponsor submits a proposal for pediatric studies for another indication to another division. Can the division that received the proposal respond with a Written Request for pediatric studies to qualify for an exclusivity extension?

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