View all text of Part A [§ 351 - § 360n-2]
§ 356–1. Accelerated approval of priority countermeasures
(a) In general
The 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
1 See References in Text note below.
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
(2) an application for the investigation of the drug under section 355(i) of this title or section 262(a)(3) of title 42.
Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.
(b) Use of animal trials
(c) Priority review of drugs and biological products
(d) Definitions
For purposes of this title: 1
(1) The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4) 1 of title 42.
(2) The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.
(Pub. L. 107–188, title I, § 122, June 12, 2002, 116 Stat. 613.)