Sec. 303. Rule of construction
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Nothing in this subtitle, the amendments made by this subtitle, or in section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ), shall be construed as— prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle; or in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 505–1, with respect to such covered product. In this section, the terms covered product , eligible product developer , license holder , and REMS with ETASU have the meanings given such terms in section 301(a).
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- 21 USC 355–1
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Sec. 303
Rule of construction
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