Extension of exclusivity period for new qualified infectious disease products

21 U.S. Code § 355f. Extension of exclusivity period for new qualified infectious disease products

(a) Extension
If the Secretary approves an application pursuant to section 355 of this title for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 355 of this title, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 355 of this title, or the 7-year period described in section 360cc of this title, as applicable, shall be extended by 5 years.
(b) Relation to pediatric exclusivity
Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 355a of this title with respect to the drug.
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