Section 564(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(c)) is amended—
(1)
in paragraph (4), by striking and;
(2)
by redesignating paragraph (5) as paragraph (6); and
(3)
by inserting after paragraph (4) the following:
Text this section adds to the law
(5)
the authorization is based on a certification by a medical research company or sponsor that no fraudulent material statements were made, and no material information was concealed, with respect to the circumstances described under subsection (b)(1) or the criteria under this subsection; and