id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
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,,2026-05-15T20:51:22Z,,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,,2026-05-15T19:53:37Z,,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,,2026-05-15T21:37:53Z,,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,,2026-05-15T16:56:08Z,,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,,2026-05-15T18:15:10Z,,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,,2026-05-15T19:33:46Z,,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,,2026-05-15T21:35:08Z,,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,,2026-05-15T22:57:37Z,,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,,2026-05-15T20:28:02Z,,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,,2026-05-15T18:18:45Z,,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,,2026-05-15T18:10:17Z,,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,,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,,2026-05-15T21:26:05Z,,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,,2026-05-15T23:01:41Z,,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,,2026-05-16T01:50:33Z,,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,,,2026-05-14T17:42:39Z,,0,0,09000064b92d5011
FDA-2026-P-5454-0014,FDA,FDA-2026-P-5454,"Reference 12 - de Araújo-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,,,2026-05-14T17:42:56Z,,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,,,2026-05-14T17:43:00Z,,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,,2026-05-14T18:02:11Z,,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,,2026-05-14T17:41:43Z,,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,,2026-05-14T17:41:38Z,,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,,2026-05-14T18:12:30Z,,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-Müllerian 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,,,2026-05-14T17:42:46Z,,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,,,2026-05-14T17:41:58Z,,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,,,2026-05-14T17:42:53Z,,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,,2026-05-14T23:17:53Z,,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,,2026-05-15T00:35:04Z,,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,,,2026-05-14T23:18:09Z,,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,,,2026-05-14T23:18:14Z,,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,,2026-05-14T19:33:28Z,,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,,2026-05-14T20:05:30Z,,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,,2026-05-14T18:05:51Z,,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,,,2026-05-14T17:43:26Z,,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,,,2026-05-14T23:37:59Z,,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,,,2026-05-14T17:43:53Z,,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,,,2026-05-14T17:41:54Z,,0,0,09000064b92d500b
FDA-2026-P-5454-0006,FDA,FDA-2026-P-5454,"References 4 - Guzmán-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,,,2026-05-14T17:42:16Z,,0,0,09000064b92d500e
FDA-2026-P-5454-0007,FDA,FDA-2026-P-5454,"References 5 - Górawski, 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,,,2026-05-14T17:42:31Z,,0,0,09000064b92d500f
FDA-2026-P-5578-0002,FDA,FDA-2026-P-5578,Acknowledgement Letter from FDA DMB to Appco Pharma LLC,Other,Acknowledgement Letter/Receipt,2026-05-14T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T23:17:57Z,,0,0,09000064b92d8f63
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,,,2026-05-14T23:38:03Z,,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,,,2026-05-14T23:38:07Z,,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,,,2026-05-14T17:42:12Z,,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,,,2026-05-14T17:43:29Z,,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,,,2026-05-14T17:44:02Z,,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,,,2026-05-14T17:43:48Z,,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,,2026-05-14T23:37:28Z,,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,,2026-05-14T15:19:06Z,,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. 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,,,2026-05-14T17:43:58Z,,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,,,2026-05-14T17:42:42Z,,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,,,2026-05-14T17:43:32Z,,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,,,2026-05-14T17:42:35Z,,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,,,2026-05-14T17:42:50Z,,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,,,2026-05-14T17:43:22Z,,0,0,09000064b92d5033
FDA-2026-P-5611-0001,FDA,FDA-2026-P-5611,"Suitability Petition from Senores Pharmaceuticals, Inc",Other,Petition(s),2026-05-14T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T23:37:18Z,,1,0,09000064b92d9592
FDA-2026-P-5578-0003,FDA,FDA-2026-P-5578,Attachment 1,Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T23:18:06Z,,0,0,09000064b92d70f0
FDA-2026-N-4126-0001,FDA,FDA-2026-N-4126,Azodicarbonamide (ADA); Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:13:38Z,2026-09508,1,0,09000064b92d17fd
FDA-2026-H-4962-0001,FDA,FDA-2026-H-4962,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T16:11:53Z,,0,0,09000064b92d2875
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–S124, doi: 10.1002/jcph.1836.",Supporting & Related Material,Background Material,2026-05-13T04:00:00Z,2026,5,,,2026-05-13T23:07:12Z,,0,0,09000064b92d59a0
FDA-2018-N-4626-1057,FDA,FDA-2018-N-4626,Nomination from Stokes Pharmacy,Other,Nomination,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T22:53:42Z,,0,0,09000064b92a502f
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,,,2026-05-13T17:52:48Z,,0,0,09000064b92d40e8
FDA-2019-D-1536-0037,FDA,FDA-2019-D-1536,Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry; Draft Guidance,Other,Guidance,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T15:23:30Z,,1,0,09000064b92d0c28
FDA-2026-N-3098-0001,FDA,FDA-2026-N-3098,Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting,Notice,60 Day Proposed Information Collection,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T16:56:28Z,2026-09543,1,0,09000064b92d4966
FDA-2026-N-2526-0002,FDA,FDA-2026-N-2526,Reference List,Supporting & Related Material,Background Material,2026-05-13T04:00:00Z,2026,5,,,2026-05-13T17:52:37Z,,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,,,2026-05-13T17:52:45Z,,0,0,09000064b92d40e7
FDA-2026-H-4964-0001,FDA,FDA-2026-H-4964,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T20:07:19Z,,0,0,09000064b92d474c
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
Gastric Outlet Obstruction",Supporting & Related Material,Background Material,2026-05-13T04:00:00Z,2026,5,,,2026-05-13T23:05:03Z,,0,0,09000064b92d58f6
FDA-2026-H-5121-0001,FDA,FDA-2026-H-5121,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-14T00:04:07Z,,0,0,09000064b92d4ee4
FDA-2026-H-5050-0001,FDA,FDA-2026-H-5050,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-14T00:06:15Z,,0,0,09000064b92d4ce2
FDA-2026-H-5126-0001,FDA,FDA-2026-H-5126,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T20:18:06Z,,0,0,09000064b92d58d5
FDA-2023-D-0608-0005,FDA,FDA-2023-D-0608,Development of Local Anesthetic Drug Products With Prolonged Duration of Effect; Guidance for Industry; Draft Guidance,Other,Guidance,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T15:22:13Z,,1,0,09000064b92d0c40
FDA-2026-N-2526-0001,FDA,FDA-2026-N-2526,Butylated Hydroxytoluene (BHT); Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:01:00Z,2026-09507,1,0,09000064b92d4931
FDA-2026-H-4823-0001,FDA,FDA-2026-H-4823,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T18:56:10Z,,0,0,09000064b92d46ee
FDA-2026-H-4794-0001,FDA,FDA-2026-H-4794,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T20:54:18Z,,0,0,09000064b92d44cd
FDA-2026-H-5053-0001,FDA,FDA-2026-H-5053,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T23:02:35Z,,0,0,09000064b92d4bbf
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): 848–859, doi: 10.1002/jcph.1580.",Supporting & Related Material,Background Material,2026-05-13T04:00:00Z,2026,5,,,2026-05-13T23:07:15Z,,0,0,09000064b92d59a1
FDA-2019-N-0994-0230,FDA,FDA-2019-N-0994,"Modified Risk Tobacco Product Application: Renewal Applications for
VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.",Notice,Request for Comments,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-15T09:00:24Z,2026-09544,1,0,09000064b92d47df
FDA-2021-N-0556-0026,FDA,FDA-2021-N-0556,Development of Non-Opioid Analgesics for Acute Pain; Guidance for Industry; Draft Guidance,Other,Guidance,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T15:20:57Z,,1,0,09000064b92d0c73
FDA-1995-S-0036-0241,FDA,FDA-1995-S-0036,Public Disclosure from Boston Children's Hospital,Other,Public Disclosure,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T17:49:22Z,,0,0,09000064b92d4423
FDA-2025-N-1600-0003,FDA,FDA-2025-N-1600,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3,Notice,30 Day Proposed Information Collection,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-06-13T03:59:59Z,2026-05-13T17:17:21Z,2026-09448,1,0,09000064b92d4828
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,,,2026-05-13T17:52:41Z,,0,0,09000064b92d40e6
FDA-2026-H-4965-0001,FDA,FDA-2026-H-4965,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T20:09:56Z,,0,0,09000064b92d40a7
FDA-2026-R-5127-0001,FDA,FDA-2026-R-5127,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T22:53:38Z,,0,0,09000064b92d4bbc
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,,,2026-05-13T23:04:57Z,,0,0,09000064b92d58f5
FDA-2026-H-5052-0001,FDA,FDA-2026-H-5052,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T20:19:23Z,,0,0,09000064b92d4ce8
FDA-2023-D-1848-0023,FDA,FDA-2023-D-1848,Stimulant Use Disorders: Developing Drugs for Treatment; Guidance for Industry; Draft Guidance,Other,Guidance,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T15:18:07Z,,1,0,09000064b92d0c8f
FDA-2025-D-0610-0125,FDA,FDA-2025-D-0610,Development of Non-Opioid Analgesics for Chronic Pain; Guidance for Industry; Draft Guidance,Other,Guidance,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T15:19:21Z,,1,0,09000064b92d0c87
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,,,2026-05-13T23:35:23Z,,0,0,09000064b92d66b5
FDA-2026-P-5453-0002,FDA,FDA-2026-P-5453,Acknowledgement Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS),Other,Acknowledgement Letter/Receipt,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T23:04:37Z,,0,0,09000064b92d5159
FDA-2026-H-5054-0001,FDA,FDA-2026-H-5054,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T23:14:35Z,,0,0,09000064b92d4ee9
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,,,2026-05-13T23:05:09Z,,0,0,09000064b92d5d02
FDA-2026-H-5125-0001,FDA,FDA-2026-H-5125,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-14T00:06:58Z,,0,0,09000064b92d599b
FDA-2026-N-0005-0001,FDA,FDA-2026-N-0005,Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information,Notice,Requests for Information (RFI),2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,2026-07-14T03:59:59Z,2026-05-13T17:06:21Z,2026-09533,1,0,09000064b92d48f3
FDA-2026-H-4827-0001,FDA,FDA-2026-H-4827,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T19:16:50Z,,0,0,09000064b92d4469
FDA-2026-H-4955-0001,FDA,FDA-2026-H-4955,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T18:58:41Z,,0,0,09000064b92d443b
FDA-2025-H-3115-0002,FDA,FDA-2025-H-3115,Amended Complaint,Other,Amendment,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T18:31:59Z,,0,0,09000064b92d2a7a
FDA-2026-H-4952-0001,FDA,FDA-2026-H-4952,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T19:14:34Z,,0,0,09000064b92d445b
FDA-2026-P-5453-0001,FDA,FDA-2026-P-5453,Citizen Petition from Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS),Other,Citizen Petition,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T23:00:37Z,,1,0,09000064b92d5158
FDA-2026-H-5051-0001,FDA,FDA-2026-H-5051,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T20:57:05Z,,0,0,09000064b92d44db
FDA-2026-H-4992-0001,FDA,FDA-2026-H-4992,Complaint,Other,Complaint,2026-05-13T04:00:00Z,2026,5,2026-05-13T04:00:00Z,,2026-05-13T19:45:07Z,,0,0,09000064b92d3805
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):1450–1455.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,,,2026-05-13T23:07:08Z,,0,0,09000064b92d599f