{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and document_type = \"Supporting & Related Material\" sorted by posted_date descending", "rows": [["FDA-2026-P-5454-0009", "FDA", "FDA-2026-P-5454", "References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:42:39Z", null, 0, 0, "09000064b92d5011"], ["FDA-2026-P-5454-0014", "FDA", "FDA-2026-P-5454", "Reference 12 - de Ara\u00fajo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. 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-5454-0011", "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-5578-0004", "FDA", "FDA-2026-P-5578", "Attachment 2", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:18:09Z", null, 0, 0, "09000064b92d70f1"], ["FDA-2026-P-5578-0005", "FDA", "FDA-2026-P-5578", "Attachment 3", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:18:14Z", null, 0, 0, "09000064b92d70f2"], ["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-5611-0003", "FDA", "FDA-2026-P-5611", "attachment-1-orange-book-page", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:37:59Z", null, 0, 0, "09000064b92d874f"], ["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-5611-0004", "FDA", "FDA-2026-P-5611", "attachment-2-rld-labeling", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:38:03Z", null, 0, 0, "09000064b92d8750"], ["FDA-2026-P-5611-0005", "FDA", "FDA-2026-P-5611", "attachment-3-test-product-draft-labeling", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:38:07Z", null, 0, 0, "09000064b92d8751"], ["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. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T17:43:22Z", null, 0, 0, "09000064b92d5033"], ["FDA-2026-P-5578-0003", "FDA", "FDA-2026-P-5578", "Attachment 1", "Supporting & Related Material", "Background Material", "2026-05-14T04:00:00Z", 2026, 5, null, null, "2026-05-14T23:18:06Z", null, 0, 0, "09000064b92d70f0"], ["FDA-2026-N-0005-0003", "FDA", "FDA-2026-N-0005", "Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117\u2013S124, doi: 10.1002/jcph.1836.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:07:12Z", null, 0, 0, "09000064b92d59a0"], ["FDA-2026-N-2526-0005", "FDA", "FDA-2026-N-2526", "Reference 3 - Codex General Standard for Food Additives 2025 Food Categories", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T17:52:48Z", null, 0, 0, "09000064b92d40e8"], ["FDA-2026-N-2526-0002", "FDA", "FDA-2026-N-2526", "Reference List", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T17:52:37Z", null, 0, 0, "09000064b92d40e5"], ["FDA-2026-N-2526-0004", "FDA", "FDA-2026-N-2526", "Reference 2 - What We Eat in America Food Categories, available at https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T17:52:45Z", null, 0, 0, "09000064b92d40e7"], ["FDA-2026-P-5453-0004", "FDA", "FDA-2026-P-5453", "Attachment 2 - de la Plaza Llamas et al. - Laparoscopic Removal of a Displaced Vertical Gastric Clip Causing\nGastric Outlet Obstruction", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:05:03Z", null, 0, 0, "09000064b92d58f6"], ["FDA-2026-N-0005-0004", "FDA", "FDA-2026-N-0005", "Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848\u2013859, doi: 10.1002/jcph.1580.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:07:15Z", null, 0, 0, "09000064b92d59a1"], ["FDA-2026-N-2526-0003", "FDA", "FDA-2026-N-2526", "Reference 1 - Citizen Petition from Roger D. Middlekauff, dated December 23, 1986, available at regulations.gov in Docket No. FDA-2026-N-2526.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T17:52:41Z", null, 0, 0, "09000064b92d40e6"], ["FDA-2026-P-5453-0003", "FDA", "FDA-2026-P-5453", "Attachment 1 - Bonaldi et al. - 2024 - BariClip Outcomes and Complications from a Single-Center Experience", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:04:57Z", null, 0, 0, "09000064b92d58f5"], ["FDA-2026-N-4126-0003", "FDA", "FDA-2026-N-4126", "Reference 2 - Codex General Standard for Food Additives, available at https://www.fao.org/gsfaonline/foods/index.html.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:35:23Z", null, 0, 0, "09000064b92d66b5"], ["FDA-2026-P-5453-0005", "FDA", "FDA-2026-P-5453", "Attachment 3 - Jacobs et al. - 2017 - A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:05:09Z", null, 0, 0, "09000064b92d5d02"], ["FDA-2026-N-0005-0002", "FDA", "FDA-2026-N-0005", "Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450\u20131455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:07:08Z", null, 0, 0, "09000064b92d599f"], ["FDA-2026-N-4126-0002", "FDA", "FDA-2026-N-4126", "Reference 1 - What We Eat in America Food Categories, available at https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/.", "Supporting & Related Material", "Background Material", "2026-05-13T04:00:00Z", 2026, 5, null, null, "2026-05-13T23:35:19Z", null, 0, 0, "09000064b92d66b4"], ["FDA-2026-D-5083-0003", "FDA", "FDA-2026-D-5083", "FINAL Enforcement Priorities For ENDS Guidance Withdrawal", "Supporting & Related Material", "Background Material", "2026-05-12T04:00:00Z", 2026, 5, null, null, "2026-05-13T00:47:28Z", null, 0, 0, "09000064b92d3127"], ["FDA-2026-P-5116-0007", "FDA", "FDA-2026-P-5116", "Appendix V - Reinhardt L, et al. Systematic mapping of fluoroquinolone off-target effects in human cells reveals mitochondrial and metabolic pathway interactions. Angew Chem Int Ed. 2025.", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T23:22:24Z", null, 0, 0, "09000064b92c88ff"], ["FDA-2026-P-5194-0006", "FDA", "FDA-2026-P-5194", "Attachment 4", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T21:17:25Z", null, 0, 0, "09000064b92cfc11"], ["FDA-2026-P-5116-0005", "FDA", "FDA-2026-P-5116", "Appendix III - Hangas A, Aasumets K, Kek\u00e4l\u00e4inen NJ, Palohein\u00e4 M, Pohjoism\u00e4ki JLO, Gerhold JM. Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2. Pharmacol Res. 2018;132:101\u2013110.", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T23:22:14Z", null, 0, 0, "09000064b92c88fd"], ["FDA-2026-N-4268-0002", "FDA", "FDA-2026-N-4268", "Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-12T01:17:00Z", null, 0, 0, "09000064b92d0a0e"], ["FDA-2026-P-5194-0004", "FDA", "FDA-2026-P-5194", "Attachment 2", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T21:17:18Z", null, 0, 0, "09000064b92cfc0f"], ["FDA-2026-P-5116-0003", "FDA", "FDA-2026-P-5116", "Appendix I - FDA 2013 Safety Communication (peripheral neuropathy warning)", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T23:22:04Z", null, 0, 0, "09000064b92c88fb"], ["FDA-2026-P-5116-0004", "FDA", "FDA-2026-P-5116", "Appendix II - FDA 2015 Joint Advisory Committee Materials (FQAD / multisystem discussion)", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T23:22:09Z", null, 0, 0, "09000064b92c88fc"], ["FDA-2026-P-5194-0003", "FDA", "FDA-2026-P-5194", "Attachment 1", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T21:17:14Z", null, 0, 0, "09000064b92cfc0e"], ["FDA-2026-P-5194-0005", "FDA", "FDA-2026-P-5194", "Attachment 3", "Supporting & Related Material", "Background Material", "2026-05-11T04:00:00Z", 2026, 5, null, null, "2026-05-11T21:17:21Z", null, 0, 0, "09000064b92cfc10"], ["FDA-2026-P-5116-0006", "FDA", "FDA-2026-P-5116", "Appendix IV - Kalghatgi S, Spina CS, Costello JC, et al. Bactericidal antibiotics induce mitochondrial dysfunction and oxidative damage in mammalian cells. 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