Sec. 6. Including antifungal biological products as qualified infectious disease products
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Section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ) is amended— in subsection (a)— by inserting (or, pursuant to section 351 of the Public Health Service Act, in the case of an antifungal biological product) after pursuant to section 505 for a drug ; and by striking or the 7-year period described in section 527, and inserting the 7-year period described in section 527, or, in the case of an antifungal biological product, the 12-year period under section 351(k) of the Public Health Service Act, ; in subsection (c)— in paragraph (1), by inserting or, in the case of an antifungal biological product, section 351(a) of the Public Health Service Act after 505(b) ; and in paragraph (2), by inserting or, in the case of an antifungal biological product, section 351 of the Public Health Service Act after 505 ; in subsection (d)(1) by inserting or, in the case of an antifungal biological product, section 351(a) of the Public Health Service Act after 505(b) ; and in subsection (g), in the matter preceding paragraph (1)— by inserting (including antifungal biological products) after antifungal drug ; and by inserting or prevent after treat .
The amendments made by subsection
(a)shall apply with respect to applications for the approval of biological products under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) submitted on or after the date of the enactment of this Act. Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall update Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industry issued in January 2018, to implement the amendments made by subsection (a).
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Sec. 6
Including antifungal biological products as qualified infectious disease products
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