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withdrawn,object_id FDA-2025-P-6315-0013,FDA,FDA-2025-P-6315,Interim Response,Other,Letter(s),2026-05-12T04:00:00Z,2026,5,2026-05-12T04:00:00Z,,2026-05-12T18:26:15Z,,0,0,09000064b92cfe1a FDA-2025-P-6315-0003,FDA,FDA-2025-P-6315,Tab 1 - Ranasinghe (2023) Final,Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:04Z,,0,0,09000064b9089443 FDA-2025-P-6315-0004,FDA,FDA-2025-P-6315,Tab 2 - Draft Guidance on Inclirisan Sodium (2023),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:08Z,,0,0,09000064b9089444 FDA-2025-P-6315-0012,FDA,FDA-2025-P-6315,Tab 10 - Kaushal (2023),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:35Z,,0,0,09000064b908946c FDA-2025-P-6315-0007,FDA,FDA-2025-P-6315,Tab 5 - FDA Citizen Petition Response (2009),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:19Z,,0,0,09000064b9089467 FDA-2025-P-6315-0006,FDA,FDA-2025-P-6315,Tab 4 - Hu (2020),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:15Z,,0,0,09000064b9089466 FDA-2025-P-6315-0008,FDA,FDA-2025-P-6315,Tab 6 - Iwamoto (2017),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:22Z,,0,0,09000064b9089468 FDA-2025-P-6315-0011,FDA,FDA-2025-P-6315,Tab 9 - Dowdy (2023),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:31Z,,0,0,09000064b908946b FDA-2025-P-6315-0009,FDA,FDA-2025-P-6315,Tab 7 - Arrico (2022),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:25Z,,0,0,09000064b9089469 FDA-2025-P-6315-0002,FDA,FDA-2025-P-6315,Acknowledgement Letter from FDA DMB to Novartis Pharmaceuticals Corporation,Other,Acknowledgement Letter/Receipt,2025-11-19T05:00:00Z,2025,11,2025-11-19T05:00:00Z,,2025-11-19T21:07:51Z,,0,0,09000064b9089441 FDA-2025-P-6315-0001,FDA,FDA-2025-P-6315,Citizen Petition from Novartis Pharmaceuticals Corporation,Other,Citizen Petition,2025-11-19T05:00:00Z,2025,11,2025-11-19T05:00:00Z,,2025-11-19T21:07:33Z,,1,0,09000064b908943f FDA-2025-P-6315-0010,FDA,FDA-2025-P-6315,Tab 8 - Jahns (2022),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:28Z,,0,0,09000064b908946a FDA-2025-P-6315-0005,FDA,FDA-2025-P-6315,Tab 3 - Ebenezer (2023),Supporting & Related Material,Background Material,2025-11-19T05:00:00Z,2025,11,,,2025-11-19T21:08:12Z,,0,0,09000064b9089445