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656 rows where docket_id = "FDA-2022-N-2390" sorted by posted_date descending
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document_type 3
- Supporting & Related Material 604
- Other 47
- Notice 5
agency_id 1
- FDA 656
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2022-N-2390-0669 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) | Notice | Hearings | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T04:00:00Z | 2026-07-07T03:59:59Z | 2026-06-03T17:59:58Z | 2026-11046 | 1 | 0 | 09000064b930c153 |
| FDA-2022-N-2390-0671 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Attachment to Reference 1 CRD PROCEDURES (eff. March 28 2016) | Supporting & Related Material | Background Material | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T19:30:31Z | 0 | 0 | 09000064b930be45 | |||
| FDA-2022-N-2390-0670 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Reference 1 Case Development Order | Supporting & Related Material | Background Material | 2026-06-03T04:00:00Z | 2026 | 6 | 2026-06-03T19:28:54Z | 0 | 0 | 09000064b930be44 | |||
| FDA-2022-N-2390-0647 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 49 - 2020_10_28 NDA 205677 S-005 Driving Study ON FDRR Response | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:27Z | 0 | 0 | 09000064b92e1250 | |||
| FDA-2022-N-2390-0654 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 56 - 2020_09_02 NDA 205677 S-004 Vanda FDRR - OND Level | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:10Z | 0 | 0 | 09000064b92e125f | |||
| FDA-2022-N-2390-0661 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 63 - vp-vec-162-2102-body | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:55Z | 0 | 0 | 09000064b92e1268 | |||
| FDA-2022-N-2390-0663 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 65 - vp-vec-162-3107-body | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:04Z | 0 | 0 | 09000064b92e126a | |||
| FDA-2022-N-2390-0664 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 66 - vp-vec-162-0101-e3-16-1-01-protocol | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:11Z | 0 | 0 | 09000064b92e1277 | |||
| FDA-2022-N-2390-0667 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 69 - vp-vec-162-2102-e3-16-1-01-protocol | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:39Z | 0 | 0 | 09000064b92e127e | |||
| FDA-2022-N-2390-0668 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 70 - Protocol 3107 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:43Z | 0 | 0 | 09000064b92e127f | |||
| FDA-2022-N-2390-0636 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 38 - 2019_07_19 NDA 205677 S-004 FDA Deficiencies Preclude Discussions Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:14Z | 0 | 0 | 09000064b92dcf33 | |||
| FDA-2022-N-2390-0604 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 06 - sNDA205677-S004_JetLag_Complete-Response-Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:21Z | 0 | 0 | 09000064b92e07b1 | |||
| FDA-2022-N-2390-0611 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 13 - Vanda response to IR Jan 28, 2019 clin-info-amend-resp-fda-info-req-20190116 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:05Z | 0 | 0 | 09000064b92e07c2 | |||
| FDA-2022-N-2390-0612 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 14 - 2006_02_01 IND 54776 Special Protocol - No Agreement Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:11Z | 0 | 0 | 09000064b92e07c3 | |||
| FDA-2022-N-2390-0614 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 16 - 2006_02_23 IND 054776 FDA Response to Meeting Request | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:34Z | 0 | 0 | 09000064b92e07c7 | |||
| FDA-2022-N-2390-0618 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 20 - 2009_10_02 IND 54776 Special Protocol - No Agreement Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:55Z | 0 | 0 | 09000064b92e07d5 | |||
| FDA-2022-N-2390-0630 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 32 - summary-clin-efficacy-jet-lag-disorder | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:47Z | 0 | 0 | 09000064b92e07e5 | |||
| FDA-2022-N-2390-0595 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Certificate of Service | Other | Certificate of Service | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T04:00:00Z | 2026-05-20T15:33:34Z | 0 | 0 | 09000064b92e0701 | ||
| FDA-2022-N-2390-0646 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 48 - 2020_10_05 NDA 205677 S-004 Vanda Response to Request for Additional Information | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:19Z | 0 | 0 | 09000064b92e124f | |||
| FDA-2022-N-2390-0653 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 55 - 2020_08_04 NDA 205677 S-004 FDA Denial of FDRR from Dr Dunn (ON) | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:05Z | 0 | 0 | 09000064b92e125e | |||
| FDA-2022-N-2390-0665 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 67 - vp-vec-162-1201-e3-16-1-01-protocol | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:28Z | 0 | 0 | 09000064b92e1278 | |||
| FDA-2022-N-2390-0634 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 36 - 2019_01_28 NDA 205677 S-004 Response to IR - Info on PROs Used | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:05Z | 0 | 0 | 09000064b92dcf31 | |||
| FDA-2022-N-2390-0635 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 37 - 2019_07_19 NDA 205677 Email Noting Additional Supplement Numbers Assigned | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:10Z | 0 | 0 | 09000064b92dcf32 | |||
| FDA-2022-N-2390-0637 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 39 - 2019_09_19 NDA 205677 S-005 FDA CRL for Driving Study | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:19Z | 0 | 0 | 09000064b92dcf34 | |||
| FDA-2022-N-2390-0613 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 15 - 2006_02_13 IND 054776 Meeting Request Package | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:16Z | 0 | 0 | 09000064b92e07c6 | |||
| FDA-2022-N-2390-0621 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 23 - ICSD-3 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:37:23Z | 0 | 0 | 09000064b92e07d8 | |||
| FDA-2022-N-2390-0623 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 25 - cover 0086 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:02Z | 0 | 0 | 09000064b92e07da | |||
| FDA-2022-N-2390-0627 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 29 - synopses-indiv-studies | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:32Z | 0 | 0 | 09000064b92e07e1 | |||
| FDA-2022-N-2390-0631 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 33 - proposed draft labeling clean | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:52Z | 0 | 0 | 09000064b92e07e6 | |||
| FDA-2022-N-2390-0645 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 47 - 2020_09_23 NDA 205677 S-004 Vanda Response to Request for Additional Information | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:14Z | 0 | 0 | 09000064b92e124e | |||
| FDA-2022-N-2390-0649 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 51 - 2018_02_28 Study 3107 Statistical Analysis Plan NDA 205677 Oct 16, 2018 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:48Z | 0 | 0 | 09000064b92e125a | |||
| FDA-2022-N-2390-0651 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 53 - 2019_08_16 NDA 205677 S-004 FDA Unireview for JLD Indication | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:57Z | 0 | 0 | 09000064b92e125c | |||
| FDA-2022-N-2390-0658 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 60 - SAP 3101 vp-vec-162-3101-e3-16-1-09 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:42Z | 0 | 0 | 09000064b92e1263 | |||
| FDA-2022-N-2390-0659 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 61 - vp-vec-162-1201-body | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:46Z | 0 | 0 | 09000064b92e1266 | |||
| FDA-2022-N-2390-0662 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 64 - vp-vec-162-3101-body | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:00Z | 0 | 0 | 09000064b92e1269 | |||
| FDA-2022-N-2390-0599 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 01- Billy Dunn Vanda aNDA 205677 S005 Dispute Appeal Denied Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:45Z | 0 | 0 | 09000064b92e0788 | |||
| FDA-2022-N-2390-0600 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 02 - NDA205677S4_TypeA-Meeting-Minutes | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:50Z | 0 | 0 | 09000064b92e07a1 | |||
| FDA-2022-N-2390-0601 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 03 - Billy Dunn Vanda SDNA 205677 S004 Dispute Appeal Denied | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:55Z | 0 | 0 | 09000064b92e07a2 | |||
| FDA-2022-N-2390-0605 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 07 - NDA205677-S004_Unireview | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:26Z | 0 | 0 | 09000064b92e07b3 | |||
| FDA-2022-N-2390-0609 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 11 - NDA 205677 Response to IR September 23, 2020 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:55Z | 0 | 0 | 09000064b92e07bf | |||
| FDA-2022-N-2390-0616 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 18 - 2009_07_20 IND 54776 Meeting Minutes for June 26, 2009 Meeting | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:45Z | 0 | 0 | 09000064b92e07c9 | |||
| FDA-2022-N-2390-0617 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 19 - 2009_09_04 IND 54776 Revised Meeting Minutes for June 26, 2009 Meeting | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:51Z | 0 | 0 | 09000064b92e07ca | |||
| FDA-2022-N-2390-0624 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 26 - S004 Cover Letter | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:07Z | 0 | 0 | 09000064b92e07de | |||
| FDA-2022-N-2390-0629 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 31 - clinical-overview | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:42Z | 0 | 0 | 09000064b92e07e4 | |||
| FDA-2022-N-2390-0642 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 44 - 2020_02_11 NDA 205677 S-004 FDA FDRR Meeting Minutes (finalized 10-28-20) | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:59Z | 0 | 0 | 09000064b92e1247 | |||
| FDA-2022-N-2390-0643 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 45 - 2020_09_15 NDA 205677 S-004 FDA Acknowledges FDRR to Dr Stein delegated to Dr Thanh Hai (OND) | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:05Z | 0 | 0 | 09000064b92e124a | |||
| FDA-2022-N-2390-0650 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 52 - 2019_07_23 NDA 205677 S-004 Clinical Outcome Assessment Consult | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:52Z | 0 | 0 | 09000064b92e125b | |||
| FDA-2022-N-2390-0655 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 57 - 2020_10_21 NDA 205677 S-004 FDA Denial of FDRR from Dr Thanh Hai (OND) | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:15Z | 0 | 0 | 09000064b92e1260 | |||
| FDA-2022-N-2390-0656 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 58 - Final SAP vp-vec-162-3107-e3-16-1-09 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:20Z | 0 | 0 | 09000064b92e1261 | |||
| FDA-2022-N-2390-0660 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 62 - vp-vec-162-0101-summary-report | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:50Z | 0 | 0 | 09000064b92e1267 | |||
| FDA-2022-N-2390-0633 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 35 - 2018_12_06 NDA 205677 S-004 Response to IR - Regulatory History of Studies 3101 and 3107 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:01Z | 0 | 0 | 09000064b92dcf30 | |||
| FDA-2022-N-2390-0639 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 41 - 2020_01_03 NDA 205677 S-004 Vanda FDRR - ON Level | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:44Z | 0 | 0 | 09000064b92dcf36 | |||
| FDA-2022-N-2390-0597 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Index of Documents Vanda JLD Hearing - 05/15/2026 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:13Z | 0 | 0 | 09000064b92e0705 | |||
| FDA-2022-N-2390-0598 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Indices to Vanda Exhibits in Appendix I and II | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:21Z | 0 | 0 | 09000064b92e0706 | |||
| FDA-2022-N-2390-0603 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 05 - Mary Thanh Hai Dispute Denial Letter_sNDA 205677-004 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:04Z | 0 | 0 | 09000064b92e07ac | |||
| FDA-2022-N-2390-0625 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 27 - summary-clin-safety | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:12Z | 0 | 0 | 09000064b92e07df | |||
| FDA-2022-N-2390-0596 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | CDER's 12.85 Narrative Position Statement - Tasimelteon Jet Lag Matter | Other | Disclosure of Date and Information | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T04:00:00Z | 2026-05-20T15:33:36Z | 0 | 0 | 09000064b92e0703 | ||
| FDA-2022-N-2390-0594 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Cover Letter - 12.85 Submission | Other | Letter(s) | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T04:00:00Z | 2026-05-20T15:33:32Z | 0 | 0 | 09000064b92e06ff | ||
| FDA-2022-N-2390-0652 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 54 - 2019_09_30 NDA 205677 S-004 FDA Type A Meeting Minutes | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:01Z | 0 | 0 | 09000064b92e125d | |||
| FDA-2022-N-2390-0657 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 59 - SAP 2102 vp-vec-162-2102-e3-16-1-09 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:41:25Z | 0 | 0 | 09000064b92e1262 | |||
| FDA-2022-N-2390-0666 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 68 - vp-vec-162-3101-e3-16-1-01 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:42:32Z | 0 | 0 | 09000064b92e127d | |||
| FDA-2022-N-2390-0640 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 42 - 2020_01_16 NDA 205677 S-004 FDA Acknowledges FDRR forwarded to Dr Dunn (ON) | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:49Z | 0 | 0 | 09000064b92dcf37 | |||
| FDA-2022-N-2390-0602 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 04 - Final Agency Decision | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:34:59Z | 0 | 0 | 09000064b92e07a4 | |||
| FDA-2022-N-2390-0607 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 09 - IND 128352 new protocol Aug 16, 2016 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:46Z | 0 | 0 | 09000064b92e07ba | |||
| FDA-2022-N-2390-0610 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 12 - Vanda Pharmaceuticals FDA Update for HETLIOZ in the Treatment of Jet Lag Disorder | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:00Z | 0 | 0 | 09000064b92e07c1 | |||
| FDA-2022-N-2390-0615 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 17 - 2007_05_30 IND 54776 Meeting Minutes for Apr 30, 2007 Meeting | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:36:38Z | 0 | 0 | 09000064b92e07c8 | |||
| FDA-2022-N-2390-0619 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 21 - 2015_07_13 IND 054776 Meeting Minutes for June 15, 2015 Meeting | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:37:13Z | 0 | 0 | 09000064b92e07d6 | |||
| FDA-2022-N-2390-0626 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 28 - synopses-indiv-studies 1 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:28Z | 0 | 0 | 09000064b92e07e0 | |||
| FDA-2022-N-2390-0628 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 30 - tabular-listing | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:37Z | 0 | 0 | 09000064b92e07e3 | |||
| FDA-2022-N-2390-0644 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 46 - 2020_09_15 NDA 205677 S-004 FDA Interim Response to FDRR - FDA Requests Additional Information | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:09Z | 0 | 0 | 09000064b92e124b | |||
| FDA-2022-N-2390-0648 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 50 - 2019_08_16 NDA 205677 S-004 FDA CRL for JLD Indication | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:40:41Z | 0 | 0 | 09000064b92e1259 | |||
| FDA-2022-N-2390-0638 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 40 - 2019_09_27 NDA 205677 S-004 Type A Meeting Preliminary Comments | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:23Z | 0 | 0 | 09000064b92dcf35 | |||
| FDA-2022-N-2390-0641 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 43 - 2020_01_31 NDA 205677 S-004 FDA Interim Response to FDRR - FDA Requests Meeting | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:39:54Z | 0 | 0 | 09000064b92dcf38 | |||
| FDA-2022-N-2390-0606 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 08 - IND 128352 new protocol 3107 Sep 15, 2017 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:32Z | 0 | 0 | 09000064b92e07b8 | |||
| FDA-2022-N-2390-0608 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 10 - NCT03291041 A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:35:51Z | 0 | 0 | 09000064b92e07be | |||
| FDA-2022-N-2390-0620 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 22 - BEST Bookshelf_NBK326791 | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:37:18Z | 0 | 0 | 09000064b92e07d7 | |||
| FDA-2022-N-2390-0622 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 24 - annotated draft labeling | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:37:29Z | 0 | 0 | 09000064b92e07d9 | |||
| FDA-2022-N-2390-0632 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | 34 - 2013_12_18 NDA 205677 Clinical Review | Supporting & Related Material | Background Material | 2026-05-20T04:00:00Z | 2026 | 5 | 2026-05-20T15:38:56Z | 0 | 0 | 09000064b92e07e7 | |||
| FDA-2022-N-2390-0591 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Letter from FDA OC to McDermott Will & Emery | Other | Letter(s) | 2026-04-14T04:00:00Z | 2026 | 4 | 2026-04-14T04:00:00Z | 2026-04-14T23:02:45Z | 0 | 0 | 09000064b927ab19 | ||
| FDA-2022-N-2390-0592 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda letter re CDER submissions | Other | Letter(s) | 2026-04-14T04:00:00Z | 2026 | 4 | 2026-04-14T04:00:00Z | 2026-04-14T23:11:31Z | 0 | 0 | 09000064b927c731 | ||
| FDA-2022-N-2390-0590 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Letter from McDermott Will & Schulte (on behalf of Vanda Pharmaceuticals Inc.) to FDA OC | Other | Letter(s) | 2026-04-08T04:00:00Z | 2026 | 4 | 2026-04-08T04:00:00Z | 2026-04-08T16:11:32Z | 0 | 0 | 09000064b925c72d | ||
| FDA-2022-N-2390-0589 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Letter from McDermott Will & Schulte (on behalf of Vanda Pharmaceuticals Inc.) to FDA OC | Other | Letter(s) | 2026-03-17T04:00:00Z | 2026 | 3 | 2026-03-17T04:00:00Z | 2026-03-17T20:33:09Z | 0 | 0 | 09000064b921d823 | ||
| FDA-2022-N-2390-0588 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Letter from FDA OC to McDermott Will & Emery (on behalf of Vanda Pharmaceuticals Inc.) and FDA OCC | Other | Letter(s) | 2026-03-03T05:00:00Z | 2026 | 3 | 2026-03-03T05:00:00Z | 2026-03-04T01:46:34Z | 0 | 0 | 09000064b91ed918 | ||
| FDA-2022-N-2390-0587 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Hearing Request for sNDA 205677-004 (tasimelteon) | Other | Request for Hearing | 2026-02-26T05:00:00Z | 2026 | 2 | 2026-02-26T05:00:00Z | 2026-02-27T00:15:15Z | 0 | 0 | 09000064b91df99f | ||
| FDA-2022-N-2390-0586 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Hearing Request for sNDA 205677-004 (tasimelteon) | Other | Request for Hearing | 2026-02-09T05:00:00Z | 2026 | 2 | 2026-02-09T05:00:00Z | 2026-02-09T23:37:26Z | 0 | 0 | 09000064b919a1ca | ||
| FDA-2022-N-2390-0585 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Revised Letter re: CDER and Vanda’s Joint Request | Other | Letter(s) | 2025-10-21T04:00:00Z | 2025 | 10 | 2025-10-21T04:00:00Z | 2025-10-21T17:13:39Z | 0 | 0 | 09000064b903ed93 | ||
| FDA-2022-N-2390-0584 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Letter from FDA OC to Vanda Pharmaceuticals Inc. and FDA CDER | Other | Letter(s) | 2025-10-15T04:00:00Z | 2025 | 10 | 2025-10-15T04:00:00Z | 2025-10-15T15:52:08Z | 0 | 0 | 09000064b9015606 | ||
| FDA-2022-N-2390-0581 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Pharmaceuticals Inc.'s Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability | Other | Brief | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:12Z | 0 | 0 | 09000064869b6834 | ||
| FDA-2022-N-2390-0161 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) | Notice | Notice of Denial | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-03-07T14:52:35Z | 2025-03697 | 0 | 0 | 09000064869b9231 | |
| FDA-2022-N-2390-0580 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Cover Letter from Vanda Pharmaceuticals Inc. | Other | Letter(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:04:57Z | 0 | 0 | 09000064869b682f | ||
| FDA-2022-N-2390-0582 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:31Z | 0 | 0 | 09000064869b6836 | ||
| FDA-2022-N-2390-0583 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Declaration of Daniel Combs | Other | Declaration(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:43Z | 0 | 0 | 09000064869b6838 | ||
| FDA-2022-N-2390-0132 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Vanda Pharmaceuticals Inc.’s Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability of Tasimelteon to Treat Insomnia Associated with Difficulties with Sleep Initiation | Other | Brief | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:50Z | 0 | 0 | 0900006486972393 | ||
| FDA-2022-N-2390-0133 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | First Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:56Z | 0 | 0 | 09000064869723be | ||
| FDA-2022-N-2390-0135 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Agency Decision Hetlioz for Insomnia | Other | Agency Response | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:32:32Z | 0 | 0 | 0900006486995bdc | ||
| FDA-2022-N-2390-0134 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Second Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:32:01Z | 0 | 0 | 09000064869723c0 | ||
| FDA-2022-N-2390-0131 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Cover Letter from Vanda Pharmaceuticals Inc. | Other | Letter(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:42Z | 0 | 0 | 090000648697238f | ||
| FDA-2022-N-2390-0130 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | CDER Proposed Order_ Docket No. FDA-2022-N-2390 (Vanda Pharmaceuticals Inc. Hearing Request for sNDA 205677-012) | Other | Electronic Letter | 2025-01-29T05:00:00Z | 2025 | 1 | 2025-01-29T05:00:00Z | 2025-01-29T21:43:58Z | 0 | 0 | 0900006486908a5f | ||
| FDA-2022-N-2390-0071 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Response Cover Letter from Vanda Pharmaceuticals Inc. to FDA DMB | Other | Letter(s) | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-01-07T15:56:31Z | 0 | 0 | 09000064868a3b18 | ||
| FDA-2022-N-2390-0073 | FDA | Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 | Third Declaration of Thomas Roth | Other | Declaration(s) | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-01-07T15:56:43Z | 0 | 0 | 09000064868a45ad |
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