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- Notice 159
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- 2026 · 2,192 ✖
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- FDA · 2,192 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | 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| FDA-2007-D-0369-2444 | FDA | FDA-2007-D-0369 | PSG_020151 - Draft Guidance on Venlafaxine Hydrochloride | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:22:37Z | 1 | 0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| FDA-2007-D-0369-2442 | FDA | FDA-2007-D-0369 | PSG_020144 - Draft Guidance on Nitroglycerin | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:21:57Z | 1 | 0 |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| FDA-2007-D-0369-2432 | FDA | FDA-2007-D-0369 | PSG_018084 - Draft Guidance on Tolmetin Sodium | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:18:51Z | 1 | 0 |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| FDA-2007-D-0369-2457 | FDA | FDA-2007-D-0369 | PSG_021336 - Draft Guidance on Selegiline | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:26:39Z | 1 | 0 |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| FDA-2007-D-0369-2440 | FDA | FDA-2007-D-0369 | PSG_019982 - Draft Guidance on Bisoprolol Fumarate | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:21:21Z | 1 | 0 |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| FDA-2007-D-0369-2447 | FDA | FDA-2007-D-0369 | PSG_020375 - Draft Guidance on Estradiol | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:23:38Z | 1 | 0 |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| FDA-2007-D-0369-2459 | FDA | FDA-2007-D-0369 | PSG_021427 - Draft Guidance on Duloxetine Hydrochloride | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:27:37Z | 1 | 0 |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| FDA-2007-D-0369-2461 | FDA | FDA-2007-D-0369 | PSG_021514 - Draft Guidance on Methylphenidate | Other | Guidance | 2026-02-27T05:00:00Z | 2026 | 2 | 2026-02-27T05:00:00Z | 2026-04-29T03:59:59Z | 2026-02-27T19:29:28Z | 1 | 0 |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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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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agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
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