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Animaltesting plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88
In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animaltesting not eliminate animaltesting in drug development. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. §
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Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Among the types of device testing addressed by the Implant Draft Guidance are: (1) “engineering analysis,” (2) “materials specifications,” (3) “finite element analysis,” (4) “bench model testing,” and (5) “animaltesting,” particularly when “knowledge and refinement of surgical technique. . .
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