Sec. 712. Reauthorization of orphan drug grants
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Section 5 of the Orphan Drug Act ( 21 U.S.C. 360ee ) is amended— in subsection (a)— by striking and
(3)and inserting
(3); and by inserting before the period at the end the following: , and
(4)developing regulatory science pertaining to the chemistry, manufacturing, regulatory approval of, and controls of individualized medical products to treat individuals with rare diseases or conditions ; and in subsection (c), by striking 2018 through 2022 and inserting 2023 through 2027 .
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Sec. 712
Reauthorization of orphan drug grants
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