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URL: https://doi.org/10.1016/j.reprotox.2026.109183", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:56Z", null, 0, 0, "09000064b92d5031"], ["FDA-2026-P-5454-0015", "FDA", "FDA-2026-P-5454", "Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:00Z", null, 0, 0, "09000064b92d5032"], ["FDA-2026-P-5454-0002", "FDA", "FDA-2026-P-5454", "Acknowledgment Letter from FDA DMB to Americans for Scientific Integrity", "Other", "Acknowledgement Letter/Receipt", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T17:41:43Z", null, 0, 0, "09000064b92d4fe9"], ["FDA-2026-P-5454-0001", "FDA", "FDA-2026-P-5454", "Citizen Petition from Americans for Scientific Integrity", "Other", "Citizen Petition", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T17:41:38Z", null, 1, 0, "09000064b92d4fe7"], ["FDA-2026-P-5454-0011", "FDA", "FDA-2026-P-5454", "Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-M\u00fcllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:46Z", null, 0, 0, "09000064b92d5013"], ["FDA-2026-P-5454-0004", "FDA", "FDA-2026-P-5454", "References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:41:58Z", null, 0, 0, "09000064b92d500c"], ["FDA-2026-P-5454-0013", "FDA", "FDA-2026-P-5454", "Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:53Z", null, 0, 0, "09000064b92d5030"], ["FDA-2026-P-5454-0017", "FDA", "FDA-2026-P-5454", "Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:26Z", null, 0, 0, "09000064b92d5034"], ["FDA-2026-P-5454-0021", "FDA", "FDA-2026-P-5454", "Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:53Z", null, 0, 0, "09000064b92d5038"], ["FDA-2026-P-5454-0003", "FDA", "FDA-2026-P-5454", "References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:41:54Z", null, 0, 0, "09000064b92d500b"], ["FDA-2026-P-5454-0006", "FDA", "FDA-2026-P-5454", "References 4 - Guzm\u00e1n-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:16Z", null, 0, 0, "09000064b92d500e"], ["FDA-2026-P-5454-0007", "FDA", "FDA-2026-P-5454", "References 5 - G\u00f3rawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:31Z", null, 0, 0, "09000064b92d500f"], ["FDA-2026-P-5454-0005", "FDA", "FDA-2026-P-5454", "Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:12Z", null, 0, 0, "09000064b92d500d"], ["FDA-2026-P-5454-0018", "FDA", "FDA-2026-P-5454", "Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:29Z", null, 0, 0, "09000064b92d5035"], ["FDA-2026-P-5454-0023", "FDA", "FDA-2026-P-5454", "Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc.", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:44:02Z", null, 0, 0, "09000064b92d503a"], ["FDA-2026-P-5454-0020", "FDA", "FDA-2026-P-5454", "Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:48Z", null, 0, 0, "09000064b92d5037"], ["FDA-2026-P-5454-0022", "FDA", "FDA-2026-P-5454", "Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:58Z", null, 0, 0, "09000064b92d5039"], ["FDA-2026-P-5454-0010", "FDA", "FDA-2026-P-5454", "References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:42Z", null, 0, 0, "09000064b92d5012"], ["FDA-2026-P-5454-0019", "FDA", "FDA-2026-P-5454", "Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:32Z", null, 0, 0, "09000064b92d5036"], ["FDA-2026-P-5454-0008", "FDA", "FDA-2026-P-5454", "References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:35Z", null, 0, 0, "09000064b92d5010"], ["FDA-2026-P-5454-0012", "FDA", "FDA-2026-P-5454", "Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:50Z", null, 0, 0, "09000064b92d502f"], ["FDA-2026-P-5454-0016", "FDA", "FDA-2026-P-5454", "Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. 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