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21 U.S. Code § 360bbb-4a. Priority review to encourage treatments for agents that present national security threats
(a) DefinitionsIn this section:
(1) Human drug application
The term “human drug application” has the meaning given such term in section 379g(1) of this title.
(2) Priority review
The term “priority review”, with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.
(3) Priority review voucher
The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the material threat medical countermeasure application.
(4) Material threat medical countermeasure applicationThe term “material threat medical countermeasure application” means an application that—
(A) is a human drug application for a drug intended for use—
(i)
to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act [42 U.S.C. 247d–6b(c)(2)(A)(ii)]; or
(ii)
to mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such agent; and
(B)
the Secretary determines eligible for priority review;
(C)
is approved after December 13, 2016; and
(D) is for—
(i)
a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or
(ii)
a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act [42 U.S.C. 262].