1.
U.S. Food and Drug Administration. Guidance Document:Exploratory IND Studies. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exploratory-ind-studies.
Ethics, policy, and legislation
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NIH Advisory Committee to the Director. ACD Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research. https://www.acd.od.nih.gov/working-groups/eprar.html.
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Stephen Dinan. EPA chief Lee Zeldin eyes ban on animal testing - Washington Times. The Washington Times. https://www.washingtontimes.com/news/2025/apr/10/epa-chief-lee-zeldin-eyes-ban-animal-testing/.
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Canadian Council on Animal Care. Ethics of Animal Investigation. Ottowa: Canadian Council on Animal Care; :2. https://ccac.ca/Documents/Standards/Policies/Ethics_of_animal_investigation.pdf.
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FDA Center for Drug Evaluation and Research. Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program.
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U.S. Food and Drug Administration. Roadmap to Reducing Animal Testing in Preclinical Safety Studies. https://www.fda.gov/media/186092/download?attachment.
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U.S. Government Accountability Office. Animal Use in Research: Federal Agencies Should Assess and Report on Their Efforts to Develop and Promote Alternatives. Washington, DC: Government Accountability Office https://www.gao.gov/products/gao-19-629.
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Morning Consult, Physicians Committee for Responsible Medicine. U.S. Gen Pop Beliefs on Animal Testing. https://pcrm.widen.net/s/qzfxtfh7bw/animal-testing-survey.
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Aoife Milford, Eva De Clercq, Edwin Louis-Maerten, Lester D. Geneviève, Bernice S. Elger. How animal ethics committees make decisions – a scoping review of empirical studies. PLOS ONE. 20(3):e0318570. doi:10.1371/journal.pone.0318570
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U.S. Food and Drug Administration. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs.