21 USC 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 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
Terms Used In 21 USC 356-1
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
A drug for which approval is sought under section 355(b) of this title or section 262 of title 42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 1 may be designated as a fast track product for purposes of this section.
(c) Priority review of drugs and biological products
A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.
(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.