Sec. 2081. Sense of Congress
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/bill/114/hr/6/rh/section-2081A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
It is the sense of Congress that the Food and Drug Administration should continue to expedite the approval of drugs designated as breakthrough therapies pursuant to section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ) by approving drugs so designated as early as possible in the clinical development process, regardless of the phase of development, provided that the Secretary of Health and Human Services determines that an application for such a drug meets the standards of evidence of safety and effectiveness under section 505 of such Act ( 21 U.S.C. 355 ), including the substantial evidence standard under subsection
(d)of such section or under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ).
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