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withdrawn,object_id FDA-2026-N-0131-0001,FDA,FDA-2026-N-0131,FDA Rare Disease Innovation Hub Future Programming; Request for Comments,Notice,Request for Comments,2026-01-30,2026,1,2026-01-30,2027-01-01,2026-03-22 09:00:09,2026-01903,1,0,09000064b91893ee FDA-2016-D-1280-0005,FDA,FDA-2016-D-1280,"Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule",Notice,Announcement,2026-04-06,2026,4,2026-04-06,2026-10-02,2026-04-07 09:00:25,2026-06660,1,0,09000064b9253dbc FDA-2025-E-2426-0006,FDA,FDA-2025-E-2426,Determination of Regulatory Review Period for Purposes of Patent Extension; BLUJEPA,Notice,Determinations,2026-02-13,2026,2,2026-02-13,2026-08-13,2026-02-13 20:03:13,2026-02901,1,0,09000064b91aa6fb FDA-2025-E-0152-0006,FDA,FDA-2025-E-0152,Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY,Notice,Determinations,2026-02-06,2026,2,2026-02-06,2026-08-06,2026-02-06 20:05:43,2026-02388,1,0,09000064b919467e FDA-2025-E-0153-0006,FDA,FDA-2025-E-0153,Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY,Notice,Determinations,2026-02-06,2026,2,2026-02-06,2026-08-06,2026-02-06 20:06:34,2026-02388,1,0,09000064b919467f FDA-2024-E-3539-0006,FDA,FDA-2024-E-3539,Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ,Notice,Determinations,2026-02-06,2026,2,2026-02-06,2026-08-06,2026-02-14 13:19:52,2026-02387,1,0,09000064b9195b4d FDA-2025-E-0154-0006,FDA,FDA-2025-E-0154,Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY,Notice,Determinations,2026-02-06,2026,2,2026-02-06,2026-08-06,2026-02-06 20:07:01,2026-02388,1,0,09000064b9195c17 FDA-2026-N-3273-0001,FDA,FDA-2026-N-3273,"Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments",Notice,Request for Comments,2026-04-15,2026,4,2026-04-15,2026-07-24,2026-04-15 17:05:22,2026-07248,1,0,09000064b9282224 FDA-2026-P-0749-0001,FDA,FDA-2026-P-0749,Citizen Petition from Apotex Inc.,Other,Citizen Petition,2026-01-26,2026,1,2026-01-26,2026-07-23,2026-01-27 01:08:18,,1,0,09000064b9182c73 FDA-2026-D-1255-0002,FDA,FDA-2026-D-1255,Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry,Other,Guidance,2026-04-15,2026,4,2026-04-15,2026-07-15,2026-04-16 09:00:16,,1,0,09000064b9282a2a FDA-2023-N-0119-0020,FDA,FDA-2023-N-0119,"Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments",Notice,Request for Comments,2026-02-27,2026,2,2026-02-27,2026-07-11,2026-04-14 09:00:18,2026-03961,1,0,09000064b91e326c FDA-2026-N-2366-0001,FDA,FDA-2026-N-2366,Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments,Notice,Request for Comments,2026-03-23,2026,3,2026-03-23,2026-06-30,2026-04-12 09:00:14,2026-05573,1,0,09000064b922c21a FDA-2026-N-2742-0001,FDA,FDA-2026-N-2742,Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification,Notice,60 Day Proposed Information Collection,2026-04-10,2026,4,2026-04-10,2026-06-10,2026-04-10 18:01:37,2026-06936,1,0,09000064b926825a FDA-2026-N-2743-0001,FDA,FDA-2026-N-2743,"Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503",Notice,60 Day Proposed Information Collection,2026-04-10,2026,4,2026-04-10,2026-06-10,2026-04-10 18:22:24,2026-06935,1,0,09000064b926821b FDA-2026-N-2915-0001,FDA,FDA-2026-N-2915,Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices,Notice,60 Day Proposed Information Collection,2026-04-10,2026,4,2026-04-10,2026-06-10,2026-04-10 17:47:50,2026-06906,1,0,09000064b9268328 FDA-2026-N-2431-0001,FDA,FDA-2026-N-2431,Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings,Notice,60 Day Proposed Information Collection,2026-04-07,2026,4,2026-04-07,2026-06-09,2026-04-14 19:40:33,2026-06719,1,0,09000064b9255485 FDA-2025-E-0863-0006,FDA,FDA-2025-E-0863,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:37:03,2026-06478,1,0,09000064b924cccb FDA-2025-E-0845-0006,FDA,FDA-2025-E-0845,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:34:01,2026-06478,1,0,09000064b924dac3 FDA-2025-E-0866-0006,FDA,FDA-2025-E-0866,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:42:13,2026-06478,1,0,09000064b924ccce FDA-2025-E-0372-0005,FDA,FDA-2025-E-0372,Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:52:42,2026-06476,1,0,09000064b924da88 FDA-2025-E-3074-0006,FDA,FDA-2025-E-3074,Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:57:30,2026-06480,1,0,09000064b924c470 FDA-2025-E-0871-0006,FDA,FDA-2025-E-0871,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:49:10,2026-06478,1,0,09000064b924c46e FDA-2025-E-3073-0006,FDA,FDA-2025-E-3073,Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:55:54,2026-06480,1,0,09000064b924da86 FDA-2025-E-3626-0006,FDA,FDA-2025-E-3626,Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:59:57,2026-06479,1,0,09000064b924d98d FDA-2025-E-0870-0006,FDA,FDA-2025-E-0870,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:48:07,2026-06478,1,0,09000064b924c46d FDA-2026-N-2740-0001,FDA,FDA-2026-N-2740,Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Customer Service Satisfaction Surveys,Notice,60 Day Proposed Information Collection,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:29:44,2026-06482,1,0,09000064b924dac4 FDA-2025-E-0868-0006,FDA,FDA-2025-E-0868,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:44:23,2026-06478,1,0,09000064b924c0e1 FDA-2025-E-0865-0006,FDA,FDA-2025-E-0865,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:39:45,2026-06478,1,0,09000064b924cccd FDA-2025-E-1672-0007,FDA,FDA-2025-E-1672,Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 18:06:28,2026-06477,1,0,09000064b924d940 FDA-2014-E-2328-0006,FDA,FDA-2014-E-2328,Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 18:09:13,2026-06483,1,0,09000064b924d4f5 FDA-2025-E-0864-0006,FDA,FDA-2025-E-0864,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:38:27,2026-06478,1,0,09000064b924cccc FDA-2025-E-0872-0006,FDA,FDA-2025-E-0872,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:50:02,2026-06478,1,0,09000064b924c46f FDA-2025-E-0867-0006,FDA,FDA-2025-E-0867,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:43:31,2026-06478,1,0,09000064b924c0e0 FDA-2025-E-0158-0006,FDA,FDA-2025-E-0158,Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 18:04:00,2026-06481,1,0,09000064b924d942 FDA-2025-E-0869-0006,FDA,FDA-2025-E-0869,Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY,Notice,Determinations,2026-04-03,2026,4,2026-04-03,2026-06-03,2026-04-03 17:45:32,2026-06478,1,0,09000064b924ba07 FDA-2026-C-3071-0001,FDA,FDA-2026-C-3071,"Filing of Color Additive Petition: International Association of Color Manufacturers; Request to Amend the Color Additive Regulations to Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride",Proposed Rule,Petition,2026-04-01,2026,4,2026-04-01,2026-06-02,2026-04-01 17:16:12,2026-06295,1,0,09000064b9249960 FDA-2026-N-0809-0001,FDA,FDA-2026-N-0809,Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments,Notice,Request for Comments,2026-03-03,2026,3,2026-03-03,2026-06-02,2026-04-13 09:00:28,2026-04196,1,0,09000064b91ed501 FDA-2026-N-2476-0001,FDA,FDA-2026-N-2476,"Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments",Notice,Request for Comments,2026-03-31,2026,3,2026-03-31,2026-06-02,2026-04-10 09:00:28,2026-06184,1,0,09000064b92439d6 FDA-2026-N-2590-0001,FDA,FDA-2026-N-2590,Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests,Proposed Rule,Request for Comment,2026-03-30,2026,3,2026-03-30,2026-05-30,2026-04-13 09:00:30,2026-06064,1,0,09000064b92437b6 FDA-2024-E-5140-0006,FDA,FDA-2024-E-5140,Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM,Notice,Determinations,2025-11-24,2025,11,2025-11-24,2026-05-27,2026-01-24 13:16:48,2025-20667,1,0,09000064b908e3f0 FDA-2024-E-5139-0006,FDA,FDA-2024-E-5139,Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM,Notice,Determinations,2025-11-24,2025,11,2025-11-24,2026-05-27,2026-01-24 13:16:48,2025-20667,1,0,09000064b908e3ef FDA-2024-E-5141-0006,FDA,FDA-2024-E-5141,Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM,Notice,Determinations,2025-11-24,2025,11,2025-11-24,2026-05-27,2026-01-24 13:16:50,2025-20667,1,0,09000064b9092f99 FDA-2024-E-5681-0006,FDA,FDA-2024-E-5681,"Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM",Notice,Determinations,2025-11-24,2025,11,2025-11-24,2026-05-27,2025-11-24 19:32:14,2025-20668,1,0,09000064b9093521 FDA-2026-N-2365-0001,FDA,FDA-2026-N-2365,Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees,Notice,60 Day Proposed Information Collection,2026-03-23,2026,3,2026-03-23,2026-05-23,2026-03-23 17:37:47,2026-05620,1,0,09000064b922c25e FDA-2026-N-2364-0001,FDA,FDA-2026-N-2364,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees",Notice,60 Day Proposed Information Collection,2026-03-23,2026,3,2026-03-23,2026-05-23,2026-03-25 09:00:29,2026-05623,1,0,09000064b922c187 FDA-2025-D-2837-0002,FDA,FDA-2025-D-2837,Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Guidance for Industry - Draft Guidance,Other,Guidance,2026-02-20,2026,2,2026-02-20,2026-05-22,2026-02-20 20:47:16,,1,0,09000064b91c9d9a FDA-2026-N-1304-0001,FDA,FDA-2026-N-1304,Agenda for the U.S. Food and Drug Administration (FDA) Virtual Public Meeting Food Allergen Thresholds and Their Potential Applications 2-18-2026,Other,Agenda,2026-02-18,2026,2,2026-02-18,2026-05-20,2026-04-10 09:00:23,,1,0,09000064b91b5eeb FDA-2025-N-5996-0001,FDA,FDA-2025-N-5996,Medical Devices; Radiology Devices; Classification of Blood Irradiators,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2026-03-18,2026,3,2026-03-18,2026-05-19,2026-03-29 09:00:14,2026-05320,1,0,09000064b92216a5 FDA-2025-N-5995-0001,FDA,FDA-2025-N-5995,Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2026-03-18,2026,3,2026-03-18,2026-05-19,2026-03-21 09:00:16,2026-05322,1,0,09000064b92215cb FDA-2026-N-1849-0001,FDA,FDA-2026-N-1849,Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission,Notice,60 Day Proposed Information Collection,2026-03-19,2026,3,2026-03-19,2026-05-19,2026-03-19 17:24:48,2026-05329,1,0,09000064b9224334 FDA-2026-N-2279-0001,FDA,FDA-2026-N-2279,Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR–20); Request for Comments,Notice,Request for Comments,2026-03-18,2026,3,2026-03-18,2026-05-19,2026-04-03 09:00:22,2026-05280,1,0,09000064b922165c FDA-2025-D-6131-0002,FDA,FDA-2025-D-6131,General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance,Other,Guidance,2026-03-19,2026,3,2026-03-19,2026-05-19,2026-04-15 09:00:24,,1,0,09000064b9223609 FDA-2026-N-1736-0001,FDA,FDA-2026-N-1736,Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements,Notice,60 Day Proposed Information Collection,2026-03-13,2026,3,2026-03-13,2026-05-13,2026-03-13 17:05:05,2026-04938,1,0,09000064b92145ad FDA-2026-D-1817-0002,FDA,FDA-2026-D-1817,Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry,Other,Guidance,2026-03-11,2026,3,2026-03-11,2026-05-12,2026-04-14 09:00:19,,1,0,09000064b920c96d FDA-2011-D-0611-0094,FDA,FDA-2011-D-0611,"New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) Guidance for Industry - Draft Guidance",Other,Guidance,2026-03-10,2026,3,2026-03-10,2026-05-12,2026-03-14 09:00:14,,1,0,09000064b92071bb FDA-2025-N-4731-0052,FDA,FDA-2025-N-4731,Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments,Notice,Request for Comments,2026-04-15,2026,4,2026-04-15,2026-05-09,2026-04-15 17:08:45,2026-07335,1,0,09000064b9282192 FDA-2025-D-1504-0002,FDA,FDA-2025-D-1504,Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry,Other,Guidance,2026-03-09,2026,3,2026-03-09,2026-05-09,2026-04-10 09:00:26,,1,0,09000064b9200f6d FDA-2025-E-0493-0006,FDA,FDA-2025-E-0493,Determination of Regulatory Review Period for Purposes of Patent Extension; ENSACOVE,Notice,Determinations,2026-03-06,2026,3,2026-03-06,2026-05-06,2026-03-06 19:06:30,2026-04491,1,0,09000064b91f8458 FDA-2024-D-4388-0002,FDA,FDA-2024-D-4388,New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers Guidance for Industry - Draft Guidance,Other,Guidance,2026-03-04,2026,3,2026-03-04,2026-05-05,2026-03-09 09:00:19,,1,0,09000064b91ef6ec FDA-2026-N-2741-0001,FDA,FDA-2026-N-2741,Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information,Notice,Requests for Information (RFI),2026-04-01,2026,4,2026-04-01,2026-05-02,2026-04-14 19:40:35,2026-06294,1,0,09000064b924995a FDA-2026-N-1867-0001,FDA,FDA-2026-N-1867,"Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 220359, for Camizestrant Tablets; Supplemental New Drug Application (sNDA) 218197/S–004, for Truqap (Capivasertib) Tablets",Notice,Request for Comments,2026-03-09,2026,3,2026-03-09,2026-04-30,2026-04-16 09:00:12,2026-04497,1,0,09000064b9200842 FDA-2007-D-0369-2444,FDA,FDA-2007-D-0369,PSG_020151 - Draft Guidance on Venlafaxine Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:22:37,,1,0,09000064b91df4e6 FDA-2007-D-0369-2442,FDA,FDA-2007-D-0369,PSG_020144 - Draft Guidance on Nitroglycerin,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:21:57,,1,0,09000064b91df4d8 FDA-2007-D-0369-2432,FDA,FDA-2007-D-0369,PSG_018084 - Draft Guidance on Tolmetin Sodium,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:18:51,,1,0,09000064b91df465 FDA-2007-D-0369-2457,FDA,FDA-2007-D-0369,PSG_021336 - Draft Guidance on Selegiline,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:26:39,,1,0,09000064b91e011b FDA-2007-D-0369-2440,FDA,FDA-2007-D-0369,PSG_019982 - Draft Guidance on Bisoprolol Fumarate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:21:21,,1,0,09000064b91df4d4 FDA-2007-D-0369-2447,FDA,FDA-2007-D-0369,PSG_020375 - Draft Guidance on Estradiol,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:23:38,,1,0,09000064b91df4f2 FDA-2007-D-0369-2438,FDA,FDA-2007-D-0369,PSG_019813 - Draft Guidance on Fentanyl,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:20:47,,1,0,09000064b91df4d0 FDA-2007-D-0369-2459,FDA,FDA-2007-D-0369,PSG_021427 - Draft Guidance on Duloxetine Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:27:37,,1,0,09000064b91e011f FDA-2007-D-0369-2461,FDA,FDA-2007-D-0369,PSG_021514 - Draft Guidance on Methylphenidate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:29:28,,1,0,09000064b91e0123 FDA-2007-D-0369-2520,FDA,FDA-2007-D-0369,PSG_218466 - Draft Guidance on Alpelisib,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:50:12,,1,0,09000064b91e01d3 FDA-2007-D-0369-2511,FDA,FDA-2007-D-0369,PSG_216352 - Draft Guidance on Paliperidone Palmitate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:47:03,,1,0,09000064b91e01b4 FDA-2007-D-0369-2512,FDA,FDA-2007-D-0369,PSG_216665 - Draft Guidance on Diazoxide Choline,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:47:20,,1,0,09000064b91e01b6 FDA-2007-D-0369-2508,FDA,FDA-2007-D-0369,PSG_215431 - Draft Guidance on Meloxicam; Rizatriptan Benzoate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:46:07,,1,0,09000064b91e01ad FDA-2007-D-0369-2475,FDA,FDA-2007-D-0369,PSG_202211 - Draft Guidance on Oxybutynin,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:35:11,,1,0,09000064b91e0140 FDA-2007-D-0369-2466,FDA,FDA-2007-D-0369,PSG_022029 - Draft Guidance on Menthol; Methyl Salicylate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:31:54,,1,0,09000064b91e012d FDA-2007-D-0369-2467,FDA,FDA-2007-D-0369,PSG_022083 - Draft Guidance on Rivastigmine,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:32:28,,1,0,09000064b91e012f FDA-2007-D-0369-2464,FDA,FDA-2007-D-0369,PSG_021829 - Draft Guidance on Rotigotine,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:30:54,,1,0,09000064b91e0129 FDA-2007-D-0369-2497,FDA,FDA-2007-D-0369,PSG_213224 - Draft Guidance on Octreotide acetate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:42:17,,1,0,09000064b91e018a FDA-2007-D-0369-2490,FDA,FDA-2007-D-0369,PSG_211843 - Draft Guidance on Tiopronin,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:39:55,,1,0,09000064b91e0172 FDA-2007-D-0369-2481,FDA,FDA-2007-D-0369,PSG_207620 - Draft Guidance on Sacubitril; Valsartan,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:37:17,,1,0,09000064b91e0156 FDA-2007-D-0369-2489,FDA,FDA-2007-D-0369,PSG_211733 - Draft Guidance on Acetaminophen; Ibuprofen,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:39:39,,1,0,09000064b91e0170 FDA-2007-D-0369-2479,FDA,FDA-2007-D-0369,PSG_206089 - Draft Guidance on Testosterone Undecanoate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:36:31,,1,0,09000064b91e0152 FDA-2007-D-0369-2469,FDA,FDA-2007-D-0369,PSG_022264 - Draft Guidance on Paliperidone Palmitate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:33:09,,1,0,09000064b91e0133 FDA-2007-D-0369-2473,FDA,FDA-2007-D-0369,PSG_085635 - Draft Guidance on Testosterone Cypionate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:34:27,,1,0,09000064b91e013c FDA-2007-D-0369-2488,FDA,FDA-2007-D-0369,PSG_210868 - Draft Guidance on Lorlatinib,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:39:21,,1,0,09000064b91e016e FDA-2007-D-0369-2486,FDA,FDA-2007-D-0369,PSG_209310 - Draft Guidance on Mometasone Furoate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:38:46,,1,0,09000064b91e016a FDA-2007-D-0369-2506,FDA,FDA-2007-D-0369,PSG_215401 - Draft Guidance on Dextroamphetamine,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:45:23,,1,0,09000064b91e01a9 FDA-2007-D-0369-2522,FDA,FDA-2007-D-0369,PSG_218585 - Draft Guidance on Aceclidine Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:51:02,,1,0,09000064b91e01d7 FDA-2007-D-0369-2509,FDA,FDA-2007-D-0369,PSG_215602 - Draft Guidance on Baclofen,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:46:21,,1,0,09000064b91e01af FDA-2007-D-0369-2516,FDA,FDA-2007-D-0369,PSG_217225 - Draft Guidance on Avacincaptad Pegol Sodium,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:48:56,,1,0,09000064b91e01cb FDA-2007-D-0369-2507,FDA,FDA-2007-D-0369,PSG_215429 - Draft Guidance on Venlafaxine Besylate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:45:49,,1,0,09000064b91e01ab FDA-2007-D-0369-2443,FDA,FDA-2007-D-0369,PSG_020145 - Draft Guidance on Nitroglycerin,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:22:16,,1,0,09000064b91df4da FDA-2007-D-0369-2460,FDA,FDA-2007-D-0369,PSG_021447 - Draft Guidance on Tizanidine Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:27:59,,1,0,09000064b91e0121 FDA-2007-D-0369-2446,FDA,FDA-2007-D-0369,PSG_020357 - Draft Guidance on Metformin Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:23:14,,1,0,09000064b91df4f0 FDA-2007-D-0369-2448,FDA,FDA-2007-D-0369,PSG_020489 - Draft Guidance on Testosterone,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:23:57,,1,0,09000064b91df4f4 FDA-2007-D-0369-2454,FDA,FDA-2007-D-0369,PSG_021234 - Draft Guidance on Diclofenac Epolamine,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:25:35,,1,0,09000064b91e010a FDA-2007-D-0369-2500,FDA,FDA-2007-D-0369,PSG_214410 - Draft Guidance on Baloxavir Marboxil,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:43:31,,1,0,09000064b91e0190 FDA-2007-D-0369-2494,FDA,FDA-2007-D-0369,PSG_212516 - Draft Guidance on Duloxetine Hydrochloride,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:41:20,,1,0,09000064b91e0184 FDA-2007-D-0369-2484,FDA,FDA-2007-D-0369,PSG_208143 - Draft Guidance on Barium Sulfate,Other,Guidance,2026-02-27,2026,2,2026-02-27,2026-04-29,2026-02-27 19:38:13,,1,0,09000064b91e015c