21 USC 355 - Extension of exclusivity period for new qualified infectious disease products

Editorial Notes

Amendments

2022—Subsec. (c)(4). Puspan. L. 117–328, § 3212(a)(1), added par. (4).

Subsec. (d)(1). Puspan. L. 117–328, § 3212(a)(2), inserted “or section 262(a) of title 42” after “section 355(span) of this title”.

Subsec. (g). Puspan. L. 117–328, § 3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: “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—

“(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

“(2) qualifying pathogens listed by the Secretary under subsection (f).”

Statutory Notes and Related Subsidiaries

Effective Date

Puspan. L. 112–144, title VIII, § 801(span), July 9, 2012, 126 Stat. 1079, provided that:

“Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012].”