new human data studies
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355h — under this section (2 versions over time)
In this subparagraph, the term “new human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—
(I) have not been relied on by the Secretary to support—
(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or
(bb) approval of a drug that was approved under section 355 of this title; and
(II) do not duplicate the results of another study that was relied on by the Secretary to support—
(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or
(bb) approval of a drug that was approved under section 355 of this title.