§355f. Extension of exclusivity period for new qualified infectious disease products — Inbound Citations

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 2 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 317.1 — [Reserved]

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• 21 C.F.R. § 317.2 — List of qualifying pathogens that have the potential to pose a serious threat to public health.

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Citations to 21 U.S.C. § 355f as a whole

• 21 U.S.C. § 353d(a)(2)

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  (2) The term “period of exclusivity”, with respect to a drug approved under section 355(c) of this title, means any period of exclusivity under clause (ii), (iii), or (iv) of section 355(c)(3)(E) of this title, clause (ii), (iii), or (iv) of section 355(j)(5)(F) of this title, or section 355a, 355f, or 360cc of this title.

• 21 U.S.C. § 355(j)(7)(A)(iv)(V)

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  (V) section 355f of this title;

• 21 U.S.C. § 355a(o)(1)

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  (1) A drug for which an application has been submitted or approved under subsection (b)(2) or (j) of section 355 of this title shall not be considered ineligible for approval under that section or misbranded under section 352 of this title on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent, or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this title, or section 360cc(a) of this title, or by an extension of such exclusivity under this section or section 355f of this title.

• 21 U.S.C. § 355a(o)(3)(B)

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  (B) the availability or scope of an extension to any such exclusivity, including an extension under this section or section 355f of this title;

• 21 U.S.C. § 360a–1(b)(1)

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  (1) The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug before such drug may be approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating, detecting, preventing, or identifying a qualifying pathogen, as defined in section 505E of such Act [21 U.S.C. 355f].

Citations to §355f(a)

• 21 U.S.C. § 353(iii)(5)(C)(iv)

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  (iv) Section 355f(a) of this title.

Citations to §355f(d)

• 21 U.S.C. § 356(b)(1)

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  (1) The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition, or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title. (In this section, such a drug is referred to as a “fast track product”.)

• 21 U.S.C. § 360a–2(f)(2)

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  (2) The term “qualified infectious disease product” means a qualified infectious disease product designated under section 355f(d) of this title.

• 21 U.S.C. § 360a–2(f)(4)(A)(ii)

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  (ii) may include a qualified infectious disease product designated under section 355f(d) of this title; and

• 21 U.S.C. § 360n–1(a)

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  (a) If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.

Citations to §355f(g)

• 21 U.S.C. § 360a–1(c)

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  (c) 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.