Sec. 3. Expedited review of drugs and biological products to provide safer or more effective treatment for males or females
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Section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) is amended by adding at the end the following: The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if the drug— is intended— to avoid serious adverse events; or to treat a serious or life-threatening disease or condition; whether alone or in combination with one or more other drugs or biological products, is intended for safer or more effective treatment for men or women than a currently available product approved to treat the general population or the other sex; and is supported by results of clinical trials that include and separately examine outcomes for both men and women.
At the request of the sponsor of an eligible product described in paragraph (1), the Secretary shall designate the drug as an expedited product to provide safer or more effective treatment for males or females. The Secretary shall, with respect to each expedited product designated under this subsection, provide early and frequent communication and review of incomplete applications to the same extent and in the same manner as is provided under subsections
(b)and (d). Nothing in this subsection shall be construed— to lessen or otherwise alter the standard of safety and effectiveness required for the approval or licensing of drugs or biological products under section 505 of this Act or section 351 of the Public Health Service Act; or to authorize application of the provisions of subsection
(c)(relating to the use of surrogate endpoints) to expedited products designated under this subsection. . Subsection
(f)of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) (relating to awareness efforts), as designated by section 902(a) of Public Law 112–144, is amended— in paragraph (1), by striking and and and inserting and ; and by moving such subsection
(f)so that it follows subsection
(e)of such section 506.
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- Pub. L. 112-144
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Sec. 3
Expedited review of drugs and biological products to provide safer or more effective treatment for males or females
Pub. L.Pub. L. 112-144
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