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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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221,173 rows where agency_id = "FDA" sorted by posted_date descending

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posted_year >30

  • 2017 24,468
  • 2016 18,435
  • 2024 16,156
  • 2019 15,939
  • 2018 15,765
  • 2025 15,077
  • 2023 13,127
  • 2015 11,812
  • 2022 11,533
  • 2014 11,406
  • 2020 9,522
  • 2021 8,221
  • 2013 7,453
  • 2008 5,759
  • 2009 5,314
  • 2012 4,226
  • 2011 3,966
  • 2010 3,813
  • 2004 3,116
  • 2007 3,095
  • 2003 2,853
  • 2006 2,645
  • 2005 2,474
  • 2026 2,192
  • 2002 711
  • 1996 448
  • 2001 424
  • 2000 325
  • 1999 209
  • 1997 200
  • …

document_type 5

  • Other 142,811
  • Supporting & Related Material 55,967
  • Notice 19,583
  • Rule 1,671
  • Proposed Rule 1,141

agency_id 1

  • FDA · 221,173 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-H-1921-0001 FDA None FDA-2026-H-1921 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T18:43:51Z   0 0 09000064b91e2df4
FDA-2007-D-0369-2444 FDA None FDA-2007-D-0369 PSG_020151 - Draft Guidance on Venlafaxine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:22:37Z   1 0 09000064b91df4e6
FDA-2007-D-0369-2442 FDA None FDA-2007-D-0369 PSG_020144 - Draft Guidance on Nitroglycerin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:21:57Z   1 0 09000064b91df4d8
FDA-2007-D-0369-2432 FDA None FDA-2007-D-0369 PSG_018084 - Draft Guidance on Tolmetin Sodium Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:18:51Z   1 0 09000064b91df465
FDA-2007-D-0369-2457 FDA None FDA-2007-D-0369 PSG_021336 - Draft Guidance on Selegiline Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:26:39Z   1 0 09000064b91e011b
FDA-2007-D-0369-2440 FDA None FDA-2007-D-0369 PSG_019982 - Draft Guidance on Bisoprolol Fumarate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:21:21Z   1 0 09000064b91df4d4
FDA-2007-D-0369-2447 FDA None FDA-2007-D-0369 PSG_020375 - Draft Guidance on Estradiol Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:23:38Z   1 0 09000064b91df4f2
FDA-2007-D-0369-2459 FDA None FDA-2007-D-0369 PSG_021427 - Draft Guidance on Duloxetine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:27:37Z   1 0 09000064b91e011f
FDA-2007-D-0369-2461 FDA None FDA-2007-D-0369 PSG_021514 - Draft Guidance on Methylphenidate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:29:28Z   1 0 09000064b91e0123
FDA-2007-D-0369-2438 FDA None FDA-2007-D-0369 PSG_019813 - Draft Guidance on Fentanyl Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:20:47Z   1 0 09000064b91df4d0
FDA-2007-D-0369-2464 FDA None FDA-2007-D-0369 PSG_021829 - Draft Guidance on Rotigotine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:30:54Z   1 0 09000064b91e0129
FDA-2007-D-0369-2497 FDA None FDA-2007-D-0369 PSG_213224 - Draft Guidance on Octreotide acetate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:42:17Z   1 0 09000064b91e018a
FDA-2007-D-0369-2490 FDA None FDA-2007-D-0369 PSG_211843 - Draft Guidance on Tiopronin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:39:55Z   1 0 09000064b91e0172
FDA-2007-D-0369-2475 FDA None FDA-2007-D-0369 PSG_202211 - Draft Guidance on Oxybutynin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:35:11Z   1 0 09000064b91e0140
FDA-2007-D-0369-2466 FDA None FDA-2007-D-0369 PSG_022029 - Draft Guidance on Menthol; Methyl Salicylate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:31:54Z   1 0 09000064b91e012d
FDA-2007-D-0369-2467 FDA None FDA-2007-D-0369 PSG_022083 - Draft Guidance on Rivastigmine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:32:28Z   1 0 09000064b91e012f
FDA-2007-D-0369-2520 FDA None FDA-2007-D-0369 PSG_218466 - Draft Guidance on Alpelisib Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:50:12Z   1 0 09000064b91e01d3
FDA-2007-D-0369-2511 FDA None FDA-2007-D-0369 PSG_216352 - Draft Guidance on Paliperidone Palmitate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:47:03Z   1 0 09000064b91e01b4
FDA-2007-D-0369-2512 FDA None FDA-2007-D-0369 PSG_216665 - Draft Guidance on Diazoxide Choline Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:47:20Z   1 0 09000064b91e01b6
FDA-2007-D-0369-2508 FDA None FDA-2007-D-0369 PSG_215431 - Draft Guidance on Meloxicam; Rizatriptan Benzoate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:46:07Z   1 0 09000064b91e01ad
FDA-2026-H-1656-0001 FDA None FDA-2026-H-1656 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T21:48:13Z   0 0 09000064b91e2bfb
FDA-2026-P-2144-0003 FDA None FDA-2026-P-2144 Attachment 1 Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T22:06:13Z   0 0 09000064b91e2fca
FDA-2026-P-2144-0005 FDA None FDA-2026-P-2144 Attachment 3 Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T22:06:19Z   0 0 09000064b91e2fcc
FDA-2026-H-1788-0001 FDA None FDA-2026-H-1788 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:52:17Z   0 0 09000064b91e385c
FDA-2026-H-1959-0001 FDA None FDA-2026-H-1959 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T00:39:26Z   0 0 09000064b91e38b5
FDA-2026-H-1963-0001 FDA None FDA-2026-H-1963 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T00:49:16Z   0 0 09000064b91e30c4
FDA-2026-H-1962-0001 FDA None FDA-2026-H-1962 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T00:45:06Z   0 0 09000064b91e3dba
FDA-2007-D-0369-2481 FDA None FDA-2007-D-0369 PSG_207620 - Draft Guidance on Sacubitril; Valsartan Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:37:17Z   1 0 09000064b91e0156
FDA-2007-D-0369-2489 FDA None FDA-2007-D-0369 PSG_211733 - Draft Guidance on Acetaminophen; Ibuprofen Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:39:39Z   1 0 09000064b91e0170
FDA-2007-D-0369-2479 FDA None FDA-2007-D-0369 PSG_206089 - Draft Guidance on Testosterone Undecanoate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:36:31Z   1 0 09000064b91e0152
FDA-2007-D-0369-2469 FDA None FDA-2007-D-0369 PSG_022264 - Draft Guidance on Paliperidone Palmitate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:33:09Z   1 0 09000064b91e0133
FDA-2007-D-0369-2473 FDA None FDA-2007-D-0369 PSG_085635 - Draft Guidance on Testosterone Cypionate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:34:27Z   1 0 09000064b91e013c
FDA-2007-D-0369-2488 FDA None FDA-2007-D-0369 PSG_210868 - Draft Guidance on Lorlatinib Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:39:21Z   1 0 09000064b91e016e
FDA-2007-D-0369-2486 FDA None FDA-2007-D-0369 PSG_209310 - Draft Guidance on Mometasone Furoate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:38:46Z   1 0 09000064b91e016a
FDA-2007-D-0369-2506 FDA None FDA-2007-D-0369 PSG_215401 - Draft Guidance on Dextroamphetamine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:45:23Z   1 0 09000064b91e01a9
FDA-2007-D-0369-2522 FDA None FDA-2007-D-0369 PSG_218585 - Draft Guidance on Aceclidine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:51:02Z   1 0 09000064b91e01d7
FDA-2007-D-0369-2509 FDA None FDA-2007-D-0369 PSG_215602 - Draft Guidance on Baclofen Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:46:21Z   1 0 09000064b91e01af
FDA-2007-D-0369-2516 FDA None FDA-2007-D-0369 PSG_217225 - Draft Guidance on Avacincaptad Pegol Sodium Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:48:56Z   1 0 09000064b91e01cb
FDA-2007-D-0369-2507 FDA None FDA-2007-D-0369 PSG_215429 - Draft Guidance on Venlafaxine Besylate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:45:49Z   1 0 09000064b91e01ab
FDA-2007-D-0369-2443 FDA None FDA-2007-D-0369 PSG_020145 - Draft Guidance on Nitroglycerin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:22:16Z   1 0 09000064b91df4da
FDA-2007-D-0369-2460 FDA None FDA-2007-D-0369 PSG_021447 - Draft Guidance on Tizanidine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:27:59Z   1 0 09000064b91e0121
FDA-2007-D-0369-2446 FDA None FDA-2007-D-0369 PSG_020357 - Draft Guidance on Metformin Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:23:14Z   1 0 09000064b91df4f0
FDA-2026-H-1420-0001 FDA None FDA-2026-H-1420 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:42:51Z   0 0 09000064b91e3818
FDA-2007-D-0369-2429 FDA None FDA-2007-D-0369 PSG_012283 - Draft Guidance on Chlorthalidone Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:17:46Z   1 0 09000064b91df45f
FDA-2007-D-0369-2441 FDA None FDA-2007-D-0369 PSG_020076 - Draft Guidance on Nicotine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:21:38Z   1 0 09000064b91df4d6
FDA-2007-D-0369-2435 FDA None FDA-2007-D-0369 PSG_018891 - Draft Guidance on Clonidine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:19:51Z   1 0 09000064b91df4ca
FDA-2007-D-0369-2453 FDA None FDA-2007-D-0369 PSG_021180 - Draft Guidance on Ethinyl Estradiol; Norelgestromin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:25:18Z   1 0 09000064b91e0108
FDA-2007-D-0369-2439 FDA None FDA-2007-D-0369 PSG_019927 - Draft Guidance on Ketoconazole Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:21:03Z   1 0 09000064b91df4d2
FDA-2007-D-0369-2448 FDA None FDA-2007-D-0369 PSG_020489 - Draft Guidance on Testosterone Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:23:57Z   1 0 09000064b91df4f4
FDA-2007-D-0369-2454 FDA None FDA-2007-D-0369 PSG_021234 - Draft Guidance on Diclofenac Epolamine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:25:35Z   1 0 09000064b91e010a
FDA-2026-H-1922-0001 FDA None FDA-2026-H-1922 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T18:45:55Z   0 0 09000064b91dfe38
FDA-2007-D-0369-2500 FDA None FDA-2007-D-0369 PSG_214410 - Draft Guidance on Baloxavir Marboxil Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:43:31Z   1 0 09000064b91e0190
FDA-2007-D-0369-2494 FDA None FDA-2007-D-0369 PSG_212516 - Draft Guidance on Duloxetine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:41:20Z   1 0 09000064b91e0184
FDA-2007-D-0369-2484 FDA None FDA-2007-D-0369 PSG_208143 - Draft Guidance on Barium Sulfate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:38:13Z   1 0 09000064b91e015c
FDA-2007-D-0369-2495 FDA None FDA-2007-D-0369 PSG_212526 - Draft Guidance on Alpelisib Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:41:39Z   1 0 09000064b91e0186
FDA-2007-D-0369-2476 FDA None FDA-2007-D-0369 PSG_203479 - Draft Guidance on Clozapine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:35:30Z   1 0 09000064b91e014c
FDA-2007-D-0369-2482 FDA None FDA-2007-D-0369 PSG_207962 - Draft Guidance on Lidocaine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:37:34Z   1 0 09000064b91e0158
FDA-2007-D-0369-2523 FDA None FDA-2007-D-0369 PSG_219016 - Draft Guidance on Rilpivirine Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:51:25Z   1 0 09000064b91e01d9
FDA-2007-D-0369-2514 FDA None FDA-2007-D-0369 PSG_216962 - Draft Guidance on Foscarbidopa; Foslevodopa Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:48:20Z   1 0 09000064b91e01ba
FDA-2007-D-0369-2517 FDA None FDA-2007-D-0369 PSG_217370 - Draft Guidance on Acoltremon Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:49:14Z   1 0 09000064b91e01cd
FDA-2007-D-0369-2515 FDA None FDA-2007-D-0369 PSG_217202 - Draft Guidance on Landiolol Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:48:39Z   1 0 09000064b91e01bc
FDA-2007-D-0369-2480 FDA None FDA-2007-D-0369 PSG_206968 - Draft Guidance on Acetaminophen Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:36:59Z   1 0 09000064b91e0154
FDA-2023-N-0119-0020 FDA None FDA-2023-N-0119 Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments Notice Request for Comments 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-07-11T03:59:59Z 2026-02-27T19:57:39Z 2026-03961 1 0 09000064b91e326c
FDA-2026-H-1960-0001 FDA None FDA-2026-H-1960 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T21:40:48Z   0 0 09000064b91e2fce
FDA-2026-H-1961-0001 FDA None FDA-2026-H-1961 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T22:13:46Z   0 0 09000064b91e2bfe
FDA-2026-H-1782-0001 FDA None FDA-2026-H-1782 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:01:08Z   0 0 09000064b91e3e15
FDA-2026-H-1785-0001 FDA None FDA-2026-H-1785 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T22:16:22Z   0 0 09000064b91e37f3
FDA-2026-P-1300-0006 FDA None FDA-2026-P-1300 Attachment 1 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Package Insert Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T23:32:57Z   0 0 09000064b91e3e19
FDA-2026-H-1965-0001 FDA None FDA-2026-H-1965 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T00:10:55Z   0 0 09000064b91e3d4b
FDA-2026-H-1971-0001 FDA None FDA-2026-H-1971 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T01:24:53Z   0 0 09000064b91e30c9
FDA-2007-D-0369-2428 FDA None FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T19:14:17Z 2026-03963 0 0 09000064b91e3271
FDA-2007-D-0369-2456 FDA None FDA-2007-D-0369 PSG_021306 - Draft Guidance on Buprenorphine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:26:18Z   1 0 09000064b91e0119
FDA-2026-P-1300-0007 FDA None FDA-2026-P-1300 Attachment 2 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Approval Letter Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T23:33:00Z   0 0 09000064b91e3e1a
FDA-2026-P-2144-0002 FDA None FDA-2026-P-2144 Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. Other Acknowledgement Letter/Receipt 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T22:06:07Z   0 0 09000064b91e3859
FDA-1991-N-0191-0010 FDA Civil money penalties:biologics, drugs and medical devices FDA-1991-N-0191 Civil Money Penalties; Biologics, Drugs, and Medical Devices; Extension of Comment Period; Correction and Addition Period; Correction and Addition Notice Notice of Extension 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 1993-08-26T03:59:59Z 2026-02-28T02:00:09Z 93-17833 0 0 090000648052deaf
FDA-1991-N-0191-0002 FDA Civil money penalties:biologics, drugs and medical devices FDA-1991-N-0191 Request for Extension from Health Industry Manufacturers Association Other Request for Extension 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T01:44:11Z   0 0 090000648052de80
FDA-2026-H-1964-0001 FDA None FDA-2026-H-1964 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-28T01:59:24Z   0 0 09000064b91e4522
FDA-2007-D-0369-2492 FDA None FDA-2007-D-0369 PSG_212304 - Draft Guidance on Donepezil Hydrochloride Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:40:33Z   1 0 09000064b91e0180
FDA-2007-D-0369-2503 FDA None FDA-2007-D-0369 PSG_215039 - Draft Guidance on Alpelisib Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:44:36Z   1 0 09000064b91e0196
FDA-2007-D-0369-2493 FDA None FDA-2007-D-0369 PSG_212306 - Draft Guidance on Selinexor Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:40:55Z   1 0 09000064b91e0182
FDA-2007-D-0369-2498 FDA None FDA-2007-D-0369 PSG_213953 - Draft Guidance on Testosterone Undecanoate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:42:31Z   1 0 09000064b91e018c
FDA-2007-D-0369-2472 FDA None FDA-2007-D-0369 PSG_050440 - Draft Guidance on Cephalexin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:34:04Z   1 0 09000064b91e013a
FDA-2007-D-0369-2485 FDA None FDA-2007-D-0369 PSG_208171 - Draft Guidance on Ferric Derisomaltose Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:38:28Z   1 0 09000064b91e015e
FDA-2007-D-0369-2501 FDA None FDA-2007-D-0369 PSG_214522 - Draft Guidance on Tadalafil Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:44:01Z   1 0 09000064b91e0192
FDA-2007-D-0369-2491 FDA None FDA-2007-D-0369 PSG_212268 - Draft Guidance on Asenapine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:40:16Z   1 0 09000064b91e017e
FDA-2007-D-0369-2477 FDA None FDA-2007-D-0369 PSG_204017 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:35:51Z   1 0 09000064b91e014e
FDA-2007-D-0369-2496 FDA None FDA-2007-D-0369 PSG_213004 - Draft Guidance on Amoxicillin; Omeprazole Magnesium; Rifabutin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:41:55Z   1 0 09000064b91e0188
FDA-2007-D-0369-2434 FDA None FDA-2007-D-0369 PSG_018859 - Draft Guidance on Ribavirin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:19:33Z   1 0 09000064b91df4c8
FDA-2007-D-0369-2431 FDA None FDA-2007-D-0369 PSG_017874 - Draft Guidance on Scopolamine Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:18:30Z   1 0 09000064b91df463
FDA-2007-D-0369-2449 FDA None FDA-2007-D-0369 PSG_020538 - Draft Guidance on Estradiol Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:24:10Z   1 0 09000064b91df4f6
FDA-2007-D-0369-2462 FDA None FDA-2007-D-0369 PSG_021588 - Draft Guidance on Imatinib Mesylate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:29:47Z   1 0 09000064b91e0125
FDA-2007-D-0369-2513 FDA None FDA-2007-D-0369 PSG_216675 - Draft Guidance on Perfluorohexyloctane Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:47:39Z   1 0 09000064b91e01b8
FDA-2007-D-0369-2510 FDA None FDA-2007-D-0369 PSG_216318 - Draft Guidance on Testosterone Cypionate Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:46:43Z   1 0 09000064b91e01b1
FDA-2007-D-0369-2458 FDA None FDA-2007-D-0369 PSG_021351 - Draft Guidance on Oxybutynin Other Guidance 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 2026-04-29T03:59:59Z 2026-02-27T19:27:00Z   1 0 09000064b91e011d
FDA-2026-N-1486-0001 FDA None FDA-2026-N-1486 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate) Notice Announcement 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T20:11:11Z 2026-03925 0 0 09000064b91e323b
FDA-2026-P-1300-0005 FDA None FDA-2026-P-1300 Suitability Petition Amendment from APDM Pharmaceuticals Private Limited Other Amendment 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:32:34Z   1 0 09000064b91e3c62
FDA-2026-P-2144-0001 FDA None FDA-2026-P-2144 Suitability Petition from Hyman, Phelps & McNamara, P.C. Other Petition(s) 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T22:05:51Z   1 0 09000064b91e3853
FDA-2026-H-1786-0001 FDA None FDA-2026-H-1786 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T22:57:13Z   0 0 09000064b91e30c0
FDA-2026-H-1958-0001 FDA None FDA-2026-H-1958 Complaint Other Complaint 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:55:07Z   0 0 09000064b91e3874
FDA-1991-N-0191-0001 FDA Civil money penalties:biologics, drugs and medical devices FDA-1991-N-0191 CIVIL MONEY PENALTIES: BIOLOGICS, DRUGS, AND MEDICAL DEVICES Proposed Rule Notice of Proposed Rulemaking (NPRM) 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z 1993-07-27T03:59:59Z 2026-02-28T01:41:45Z 93-12314 0 0 090000648052de75

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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