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Can FDA ask for a new formulation in a Written Request for pediatric exclusivity?

April 26, 2017exclusivity fda formulation pediatric request written

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Can FDA ask for a new formulation in a Written Request for pediatric exclusivity?

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FDA can request a sponsor to conduct studies in all relevant pediatric populations. A sponsor will not be able to satisfy such a Written Request unless it completes studies in all relevant populations. To complete such studies, a sponsor may need to develop a new formulation.