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material threat medical countermeasure application

Defined in 1 place of the United States Code.

The 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 a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].

Source

The 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].

Source