Sentences with phrase «drug application under section»
The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act for which the priority review voucher is used.
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The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application.
The Secretary approves a drug pursuant to an application submitted under section 505 (b) of this Act or section 351 (a) of the Public Health Service Act for which the sponsor of the application used a priority review voucher issued under this section.