Comment
Author: Admin | 2025-04-28
Section 505(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(k)], as added by subsection (a).” Construction of Amendments by Pub. L. 102–282Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title. Transfer of FunctionsFor transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. Guidance on Pathogen-Focused Antibacterial Drug DevelopmentPub. L. 112–144, title VIII, § 806, July 9, 2012, 126 Stat. 1082, provided that:“(a)Draft Guidance.—Not later than June 30, 2013, in order to facilitate the development of antibacterial drugs for serious or life-threatening bacterial infections, particularly in areas of unmet need, the Secretary of Health and Human Services shall publish draft guidance that—“(1) specifies how preclinical and clinical data can be utilized to inform an efficient and streamlined pathogen-focused antibacterial drug development program that meets the approval standards of the Food and Drug Administration; and“(2) provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens.“(b)Final Guidance.—Not later than
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