§ 356–1 — Accelerated Approval Of Priority Countermeasures

(a) 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. (b) 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) 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) 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.