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2,062 rows where docket_id = "FDA-2007-D-0369" sorted by posted_date descending
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posted_year 20
document_type 3
- Other 1,828
- Notice 123
- Supporting & Related Material 111
agency_id 1
- FDA 2,062
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2007-D-0369-2535 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_210745 - Draft Guidance on Apremilast | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:31:59Z | 1 | 0 | 09000064b92eace4 | |
| FDA-2007-D-0369-2547 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_212888 - Draft Guidance on Cabotegravir; Rilpivirine | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:27Z | 1 | 0 | 09000064b92eb927 | |
| FDA-2007-D-0369-2560 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_212725 - Draft Guidance on Entrectinib | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:08Z | 1 | 0 | 09000064b92eb94e | |
| FDA-2007-D-0369-2578 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219373 - Draft Guidance on Metoprolol Tartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:49Z | 1 | 0 | 09000064b92eb996 | |
| FDA-2007-D-0369-2577 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_019962 - Draft Guidance on Metoprolol Succinate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:47Z | 1 | 0 | 09000064b92eb994 | |
| FDA-2007-D-0369-2579 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_017963 - Draft Guidance on Metoprolol Tartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:58Z | 1 | 0 | 09000064b92eb9ac | |
| FDA-2007-D-0369-2566 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021247 - Draft Guidance on Flunisolide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:22Z | 1 | 0 | 09000064b92eb97d | |
| FDA-2007-D-0369-2565 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219019 - Draft Guidance on Fitusiran Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:20Z | 1 | 0 | 09000064b92eb97b | |
| FDA-2007-D-0369-2554 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_020392 - Draft Guidance on Cysteamine Bitartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:55Z | 1 | 0 | 09000064b92eb940 | |
| FDA-2007-D-0369-2569 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_208294 - Draft Guidance on Formoterol Fumarate; Glycopyrrolate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:29Z | 1 | 0 | 09000064b92eb983 | |
| FDA-2007-D-0369-2551 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_050767 - Draft Guidance on Clindamycin Phosphate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:49Z | 1 | 0 | 09000064b92eb930 | |
| FDA-2007-D-0369-2586 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_019887 - Draft Guidance on Pentamidine Isethionate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:12Z | 1 | 0 | 09000064b92eb9bb | |
| FDA-2007-D-0369-2548 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219921 - Draft Guidance on Carboplatin | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:29Z | 1 | 0 | 09000064b92eb929 | |
| FDA-2007-D-0369-2562 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021957 - Draft Guidance on Esomeprazole Magnesium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:12Z | 1 | 0 | 09000064b92eb966 | |
| FDA-2007-D-0369-2574 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021730 - Draft Guidance on Levalbuterol Tartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:40Z | 1 | 0 | 09000064b92eb98d | |
| FDA-2007-D-0369-2576 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021850 - Draft Guidance on Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:44Z | 1 | 0 | 09000064b92eb991 | |
| FDA-2007-D-0369-2567 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021433 - Draft Guidance on Fluticasone Propionate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:24Z | 1 | 0 | 09000064b92eb97f | |
| FDA-2007-D-0369-2556 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_208742 - Draft Guidance on Dexamethasone | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:00Z | 1 | 0 | 09000064b92eb944 | |
| FDA-2007-D-0369-2540 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_207921 - Draft Guidance on Beclomethasone Dipropionate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:13Z | 1 | 0 | 09000064b92eacef | |
| FDA-2007-D-0369-2538 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219208 - Draft Guidance on Atrasentan Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:10Z | 1 | 0 | 09000064b92eaceb | |
| FDA-2007-D-0369-2549 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_050406 - Draft Guidance on Cephalexin | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:31Z | 1 | 0 | 09000064b92eb92b | |
| FDA-2007-D-0369-2592 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219943 - Draft Guidance on Selumetinib Sulfate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:25Z | 1 | 0 | 09000064b92eb9ca | |
| FDA-2007-D-0369-2582 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219389 - Draft Guidance on Mirdametinib | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:05Z | 1 | 0 | 09000064b92eb9b0 | |
| FDA-2007-D-0369-2595 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_050708 - Draft Guidance on Tacrolimus | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:36Z | 1 | 0 | 09000064b92eb9d0 | |
| FDA-2007-D-0369-2601 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_009218 - Draft Guidance on Warfarin Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:49Z | 1 | 0 | 09000064b92eb9dc | |
| FDA-2007-D-0369-2591 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_022008 - Draft Guidance on Ropinirole Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:23Z | 1 | 0 | 09000064b92eb9c8 | |
| FDA-2007-D-0369-2581 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_205641 - Draft Guidance on Mometasone Furoate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:04Z | 1 | 0 | 09000064b92eb9b2 | |
| FDA-2007-D-0369-2587 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_019561 - Draft Guidance on Potassium Chloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:14Z | 1 | 0 | 09000064b92eb9bd | |
| FDA-2007-D-0369-2583 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_212801 - Draft Guidance on Osilodrostat Phosphate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:06Z | 1 | 0 | 09000064b92eb9b4 | |
| FDA-2007-D-0369-2531 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Notice | Notice of Availability | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-05-22T17:26:17Z | 2026-10277 | 0 | 0 | 09000064b92ecd58 | |
| FDA-2007-D-0369-2536 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_202971 - Draft Guidance on Aripiprazole | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:01Z | 1 | 0 | 09000064b92eace7 | |
| FDA-2007-D-0369-2546 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_215499 - Draft Guidance on Cabotegravir | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:25Z | 1 | 0 | 09000064b92eb925 | |
| FDA-2007-D-0369-2573 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_215974 - Draft Guidance on Lenacapavir Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:38Z | 1 | 0 | 09000064b92eb98b | |
| FDA-2007-D-0369-2580 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219379 - Draft Guidance on Mirdametinib | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:00Z | 1 | 0 | 09000064b92eb9ae | |
| FDA-2007-D-0369-2543 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021929 - Draft Guidance on Budesonide; Formoterol Fumarate Dihydrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:19Z | 1 | 0 | 09000064b92eb909 | |
| FDA-2007-D-0369-2570 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_022518 - Draft Guidance on Formoterol Fumarate; Mometasone Furoate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:31Z | 1 | 0 | 09000064b92eb985 | |
| FDA-2007-D-0369-2542 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_216579 - Draft Guidance on Budesonide; Formoterol Fumarate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:17Z | 1 | 0 | 09000064b92eb904 | |
| FDA-2007-D-0369-2600 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_009218-Sol - Draft Guidance on Warfarin Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:47Z | 1 | 0 | 09000064b92eb9da | |
| FDA-2007-D-0369-2596 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_210115 - Draft Guidance on Tacrolimus | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:38Z | 1 | 0 | 09000064b92eb9d2 | |
| FDA-2007-D-0369-2597 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021395 - Draft Guidance on Tiotropium Bromide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:40Z | 1 | 0 | 09000064b92eb9d4 | |
| FDA-2007-D-0369-2558 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219876 - Draft Guidance on Dordaviprone Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:03Z | 1 | 0 | 09000064b92eb94a | |
| FDA-2007-D-0369-2575 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_008816 - Draft Guidance on Lidocaine Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:42Z | 1 | 0 | 09000064b92eb98f | |
| FDA-2007-D-0369-2541 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_020911 - Draft Guidance on Beclomethasone Dipropionate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:15Z | 1 | 0 | 09000064b92eb902 | |
| FDA-2007-D-0369-2539 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219616 - Draft Guidance on Avutometinib Potassium; Defactinib Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:11Z | 1 | 0 | 09000064b92eaced | |
| FDA-2007-D-0369-2550 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021658 - Draft Guidance on Ciclesonide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:47Z | 1 | 0 | 09000064b92eb92d | |
| FDA-2007-D-0369-2552 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_213491 - Draft Guidance on Cysteamine Bitartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:51Z | 1 | 0 | 09000064b92eb932 | |
| FDA-2007-D-0369-2588 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_006460 - Draft Guidance on Protamine Sulfate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:16Z | 1 | 0 | 09000064b92eb9bf | |
| FDA-2007-D-0369-2599 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_019594 - Draft Guidance on Ursodiol | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:44Z | 1 | 0 | 09000064b92eb9d8 | |
| FDA-2007-D-0369-2585 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_205739 - Draft Guidance on Patiromer Sorbitex Calcium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:10Z | 1 | 0 | 09000064b92eb9b9 | |
| FDA-2007-D-0369-2593 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_206406 - Draft Guidance on Tacrolimus | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:32Z | 1 | 0 | 09000064b92eb9cc | |
| FDA-2007-D-0369-2559 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_020126 - Draft Guidance on Doxepin Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:06Z | 1 | 0 | 09000064b92eb94c | |
| FDA-2007-D-0369-2534 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219423 - Draft Guidance on Amlodipine Besylate; Indapamide; Telmisartan | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:31:57Z | 1 | 0 | 09000064b92eace0 | |
| FDA-2007-D-0369-2561 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_205920 - Draft Guidance on Epinephrine | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:10Z | 1 | 0 | 09000064b92eb950 | |
| FDA-2007-D-0369-2571 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_217779 - Draft Guidance on Imetelstat Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:33Z | 1 | 0 | 09000064b92eb987 | |
| FDA-2007-D-0369-2555 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_211379 - Draft Guidance on Dexamethasone | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:57Z | 1 | 0 | 09000064b92eb942 | |
| FDA-2007-D-0369-2563 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_212102 - Draft Guidance on Fenfluramine Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:14Z | 1 | 0 | 09000064b92eb96d | |
| FDA-2007-D-0369-2533 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_214070 - Draft Guidance on Albuterol Sulfate; Budesonide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:31:55Z | 1 | 0 | 09000064b92e8dac | |
| FDA-2007-D-0369-2584 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_216490 - Draft Guidance on Palopegteriparatide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:08Z | 1 | 0 | 09000064b92eb9b7 | |
| FDA-2007-D-0369-2598 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_203214 - Draft Guidance on Tofacitinib Citrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:42Z | 1 | 0 | 09000064b92eb9d6 | |
| FDA-2007-D-0369-2589 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_219108 - Draft Guidance on Rocuronium Bromide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:19Z | 1 | 0 | 09000064b92eb9c4 | |
| FDA-2007-D-0369-2537 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_218643 - Draft Guidance on Articaine Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:07Z | 1 | 0 | 09000064b92eace9 | |
| FDA-2007-D-0369-2545 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_209819 - Draft Guidance on Buprenorphine | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:23Z | 1 | 0 | 09000064b92eb923 | |
| FDA-2007-D-0369-2544 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_212122 - Draft Guidance on Budesonide; Formoterol Fumarate; Glycopyrrolate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:21Z | 1 | 0 | 09000064b92eb917 | |
| FDA-2007-D-0369-2553 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_203389 - Draft Guidance on Cysteamine Bitartrate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:32:53Z | 1 | 0 | 09000064b92eb93e | |
| FDA-2007-D-0369-2568 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021254 - Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:26Z | 1 | 0 | 09000064b92eb981 | |
| FDA-2007-D-0369-2557 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_022122 - Draft Guidance on Diclofenac Sodium | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:02Z | 1 | 0 | 09000064b92eb948 | |
| FDA-2007-D-0369-2572 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_021527 - Draft Guidance on Ipratropium Bromide | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:35Z | 1 | 0 | 09000064b92eb989 | |
| FDA-2007-D-0369-2564 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_215341 - Draft Guidance on Finerenone | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:33:18Z | 1 | 0 | 09000064b92eb96f | |
| FDA-2007-D-0369-2532 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_020503 - Draft Guidance on Albuterol Sulfate | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:31:53Z | 1 | 0 | 09000064b92e8daa | |
| FDA-2007-D-0369-2602 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_218785 - Draft Guidance on Zanubrutinib | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:51Z | 1 | 0 | 09000064b92eb9de | |
| FDA-2007-D-0369-2590 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_020658 - Draft Guidance on Ropinirole Hydrochloride | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:21Z | 1 | 0 | 09000064b92eb9c6 | |
| FDA-2007-D-0369-2594 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations FDA-2007-D-0369 | PSG_204096 - Draft Guidance on Tacrolimus | Other | Guidance | 2026-05-22T04:00:00Z | 2026 | 5 | 2026-05-22T04:00:00Z | 2026-07-22T03:59:59Z | 2026-05-22T19:34:34Z | 1 | 0 | 09000064b92eb9ce | |
| FDA-2007-D-0369-2444 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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-2007-D-0369-2481 | FDA | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 | Industry Describing Product-Specific Bioequivalence Recommendations 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 |
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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;