Sec. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION

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## SEC. 802 ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 801, is further amended by adding at the end the following: > > #### “(13) > > Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.” > .

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U.S. Code

New drugs
§ 355

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Sec. 802

ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION

U.S.C.§ 355

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