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withdrawn,object_id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-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-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-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-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