Sec. 2. Prioritize reviews of drug applications; incentives
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Section 506C(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(g) ) is amended— in the matter preceding paragraph (1), by striking the Secretary may and inserting the Secretary shall ; in paragraph (1), by inserting prioritize and before expedite the review ; and in paragraph (2), by inserting prioritize and before expedite an inspection . Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing legislative and regulatory recommendations— to create market-based incentives or other appropriate mechanisms, sufficient to encourage— the manufacture of drugs in shortage or at risk of shortage; the domestic manufacture of finished dosage forms of such drugs; and the domestic manufacture of active pharmaceutical ingredients for such drugs; and to expand the Emerging Technology Program of the Food and Drug Administration to create or upgrade existing technologies to address drug shortage challenges and promote modern, reliable manufacturing strategies.
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Sec. 2
Prioritize reviews of drug applications; incentives
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