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Code · BILL · 117th Congress · H.R. 7667 (Reported in House) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 701

Sec. 701. Animal testing alternatives

138 words·~1 min read·/bill/117/hr/7667/rh/section-701

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Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— in subsection (b)(5)(B)(i)(II), by striking animal and inserting nonclinical tests ; in subsection (i)— in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests ; and in paragraph (2)(B), by striking animal and inserting nonclinical tests ; and after subsection (y), by inserting the following: For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.
Such test may include the following: Cell-based assays. Organ chips and microphysiological systems. Computer modeling. Other nonhuman or human biology-based test methods. Animal tests. .
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Sec. 701
Animal testing alternatives
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