Accelerated approval of priority countermeasures

21 U.S. Code § 356-1. Accelerated approval of priority countermeasures

(a) In generalThe Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e(d)(5) [1] of this title. Such a designation may be made prior to the submission of—
(1)
a request for designation by the sponsor or applicant; or
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