21 USC 356-1 - Accelerated approval of priority countermeasures

U.S Code last checked for updates: May 02, 2024

§ 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

 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.)

cite as: 21 USC 356-1