qualified infectious disease product
Defined in 3 places of the United States Code.
For purposes of this section, the term “qualified infectious disease product” has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f(g)], as added by section 801 of this Act.
Source
- 2012–present21 U.S.C. § 360a-1Food and Drugs · Clinical trials · for purposes of this section
The term "qualified infectious disease product" means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—
Source
- 2022–202621 U.S.C. § 355fFood and Drugs · Extension of exclusivity period for new qualified infectious disease products · in this section
The term “qualified infectious disease product” means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—
(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and
(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—
(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
(B) qualifying pathogens listed by the Secretary under subsection (f).
Source
- 2026–present21 U.S.C. § 355fFood and Drugs · Extension of exclusivity period for new qualified infectious disease products · in this section
The term “qualified infectious disease product” means a qualified infectious disease product designated under section 355f(d) of this title.
Source
- 2016–present21 U.S.C. § 360a-2Food and Drugs · Susceptibility test interpretive criteria for microorganisms · in this section
The term “qualified infectious disease product” means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—
Source
- 2012–202221 U.S.C. § 355fFood and Drugs · Extension of exclusivity period for new qualified infectious disease products · in this section