{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" sorted by posted_date descending", "rows": [["FDA-2025-V-0353-0004", "FDA", "FDA-2025-V-0353", "Amendment to variance from Something Good", "Other", "Amendment", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T20:51:22Z", null, 0, 0, "09000064b92da646"], ["FDA-2026-H-5254-0001", "FDA", "FDA-2026-H-5254", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T19:53:37Z", null, 0, 0, "09000064b92da640"], ["FDA-2026-H-5253-0001", "FDA", "FDA-2026-H-5253", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T21:37:53Z", null, 0, 0, "09000064b92da628"], ["FDA-2025-P-7006-0009", "FDA", "FDA-2025-P-7006", "Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.", "Other", "Grant of Petition", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T16:56:08Z", null, 0, 0, "09000064b92d515d"], ["FDA-2026-H-5252-0001", "FDA", "FDA-2026-H-5252", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T18:15:10Z", null, 0, 0, "09000064b92da5cd"], ["FDA-2026-H-5255-0001", "FDA", "FDA-2026-H-5255", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T19:33:46Z", null, 0, 0, "09000064b92db377"], ["FDA-2026-H-5250-0001", "FDA", "FDA-2026-H-5250", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T21:35:08Z", null, 0, 0, "09000064b92dadef"], ["FDA-2026-H-5248-0001", "FDA", "FDA-2026-H-5248", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T22:57:37Z", null, 0, 0, "09000064b92db36c"], ["FDA-2025-P-6262-0052", "FDA", "FDA-2025-P-6262", "Interim Response", "Other", "Letter(s)", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T20:28:02Z", null, 0, 0, "09000064b92dbaa6"], ["FDA-2026-H-5251-0001", "FDA", "FDA-2026-H-5251", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T18:18:45Z", null, 0, 0, "09000064b92da5f9"], ["FDA-2026-H-5249-0001", "FDA", "FDA-2026-H-5249", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T18:10:17Z", null, 0, 0, "09000064b92da5b9"], ["FDA-2025-N-0421-0002", "FDA", "FDA-2025-N-0421", "Oscar Bobo: Final Debarment Order", "Notice", "Statutory Debarment", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T17:48:54Z", "2026-09767", 1, 0, "09000064b92da9bd"], ["FDA-2026-H-5256-0001", "FDA", "FDA-2026-H-5256", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T21:26:05Z", null, 0, 0, "09000064b92db9f3"], ["FDA-2026-H-5257-0001", "FDA", "FDA-2026-H-5257", "Complaint", "Other", "Complaint", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-15T23:01:41Z", null, 0, 0, "09000064b92dadf5"], ["FDA-2025-P-6024-0008", "FDA", "FDA-2025-P-6024", "Final Response", "Other", "Denial", "2026-05-15T04:00:00Z", 2026, 5, "2026-05-15T04:00:00Z", null, "2026-05-16T01:50:33Z", null, 0, 0, "09000064b92dc6f6"], ["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-2022-V-0385-0004", "FDA", "FDA-2022-V-0385", "Variance Renewal Application from Brant Parrish", "Other", "Application for Variance (VAR)", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T18:02:11Z", null, 0, 0, "09000064b92d6cc8"], ["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-2025-P-6350-0004", "FDA", "FDA-2025-P-6350", "Interim Response Letter from FDA CBER to Jack Weis", "Other", "Response(s)", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T18:12:30Z", null, 0, 0, "09000064b92d7d0a"], ["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-5578-0001", "FDA", "FDA-2026-P-5578", "Suitability Petition from Appco Pharma LLC", "Other", "Petition(s)", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T23:17:53Z", null, 1, 0, "09000064b92d8f5b"], ["FDA-2026-H-5193-0001", "FDA", "FDA-2026-H-5193", "Complaint", "Other", "Complaint", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-15T00:35:04Z", null, 0, 0, "09000064b92d79e2"], ["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-H-5184-0001", "FDA", "FDA-2026-H-5184", "Complaint", "Other", "Complaint", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T19:33:28Z", null, 0, 0, "09000064b92d6ce9"], ["FDA-2026-H-5191-0001", "FDA", "FDA-2026-H-5191", "Complaint", "Other", "Complaint", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T20:05:30Z", null, 0, 0, "09000064b92d6cee"], ["FDA-2020-V-0476-0004", "FDA", "FDA-2020-V-0476", "Variance Renewal Application from Andrew Stuart", "Other", "Application for Variance (VAR)", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T18:05:51Z", null, 0, 0, "09000064b92d76f8"], ["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. 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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-5611-0002", "FDA", "FDA-2026-P-5611", "Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc", "Other", "Acknowledgement Letter/Receipt", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T23:37:28Z", null, 0, 0, "09000064b92d7cce"], ["FDA-2026-P-3630-0006", "FDA", "FDA-2026-P-3630", "Completeness Assessment Correspondence", "Other", "Assessment Document or Analysis", "2026-05-14T04:00:00Z", 2026, 5, "2026-05-14T04:00:00Z", null, "2026-05-14T15:19:06Z", null, 0, 0, "09000064b92d613f"], ["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. 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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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