In general
section 355f(d) of this titlesection 355(b) of this titlesection 262(a) of title 42If the Secretary designates a drug under as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under , or , that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.
Construction
section 355(b) of this titleNothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under that otherwise meets the criteria for the Secretary to grant priority review.
June 25, 1938, ch. 675, § 524APub. L. 112–144, title VIII, § 802(a)126 Stat. 1079Pub. L. 114–255, div. A, title III, § 3101(a)(2)(N)130 Stat. 1154Pub. L. 117–328, div. FF, title III, § 3212(b)136 Stat. 5826(, as added , , ; amended , , ; , , .)
Editorial Notes
Amendments
Pub. L. 117–328section 262(a) of title 422022—Subsec. (a). inserted “, or , that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness” before period at end.
Pub. L. 114–2552016— designated existing provisions as subsec. (a), inserted heading, substituted “the first application” for “any application”, and added subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date
Pub. L. 112–144, title VIII, § 802(b)126 Stat. 1079