Sample Case #1
A) The sponsor must receive a Written Request from FDA before submitting the pediatric studies to the NDA and these studies must be responsive to the Written Request to qualify for exclusivity. Therefore, they must receive the Written Request before submitting the pediatric studies if they wish to potentially qualify for exclusivity.
B) A deferral would be granted for the incomplete study. A deferral would include the date by which the last study should be submitted.