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Thereafter, beginning with the three-month interval ending September 30, , subsequent docket cohorts will be batched in three-month intervals.

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FDA explained its interpretation of these terms, including the criteria it will consider in evaluating whether these terms have been met, in the August 20, , order. FDA encourages interested parties to review this order, and recommends that docket submissions include supporting reference materials and information that address how the criteria described in the order are met. When sponsors use a priority review voucher to obtain a priority review of a drug application, they are required to pay a fee in order to do so.


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