home / openregs

documents

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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

17 rows where docket_id = "FDA-2022-N-2390" and posted_year = 2023 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Other 13
  • Supporting & Related Material 4

posted_year 1

  • 2023 · 17 ✖

agency_id 1

  • FDA 17
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2390-0030 FDA None FDA-2022-N-2390 Response from Vanda Pharmaceuticals Inc. Response to FDA CDER Other Response(s) 2023-10-19T04:00:00Z 2023 10 2023-10-19T04:00:00Z   2023-10-19T19:33:28Z   0 0 090000648610f7c8
FDA-2022-N-2390-0029 FDA None FDA-2022-N-2390 Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals Inc. Other Letter(s) 2023-09-29T04:00:00Z 2023 9 2023-09-29T04:00:00Z   2023-09-29T17:42:03Z   0 0 090000648600f7cf
FDA-2022-N-2390-0028 FDA None FDA-2022-N-2390 Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals, Inc to FDA CDER Other Letter(s) 2023-09-19T04:00:00Z 2023 9 2023-09-19T04:00:00Z   2023-09-19T18:30:32Z   0 0 0900006485fd20d7
FDA-2022-N-2390-0026 FDA None FDA-2022-N-2390 Participation of Chief Counsel Mark Raza in re: Proposal to Refuse to Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing Other Memo 2023-08-30T04:00:00Z 2023 8 2023-08-30T04:00:00Z   2023-08-30T19:13:12Z   0 0 0900006485f14bbc
FDA-2022-N-2390-0027 FDA None FDA-2022-N-2390 Mark Raza’s Participation in Vanda Pharmaceuticals Other Memo 2023-08-30T04:00:00Z 2023 8 2023-08-30T04:00:00Z   2023-08-30T19:13:23Z   0 0 0900006485f14bc0
FDA-2022-N-2390-0025 FDA None FDA-2022-N-2390 Vanda's Response to CDER's Proposed Order Other Response(s) 2023-08-17T04:00:00Z 2023 8 2023-08-17T04:00:00Z   2023-08-17T18:27:06Z   0 0 0900006485e77eab
FDA-2022-N-2390-0024 FDA None FDA-2022-N-2390 Vanda's Response to CDER's Proposed Order Other Response(s) 2023-08-17T04:00:00Z 2023 8 2023-08-17T04:00:00Z   2023-08-17T18:24:44Z   0 0 0900006485e60684
FDA-2022-N-2390-0020 FDA None FDA-2022-N-2390 Cover Memorandum to Vanda RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing Supporting & Related Material Background Material 2023-06-22T04:00:00Z 2023 6     2023-06-22T14:42:06Z   0 0 0900006485bb01e9
FDA-2022-N-2390-0022 FDA None FDA-2022-N-2390 Proposed Order RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing Supporting & Related Material Background Material 2023-06-22T04:00:00Z 2023 6     2023-06-22T14:42:13Z   0 0 0900006485bb0f98
FDA-2022-N-2390-0023 FDA None FDA-2022-N-2390 ICSD-3 3rd edition (2014) Insomnia RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing Supporting & Related Material Background Material 2023-06-22T04:00:00Z 2023 6     2023-06-22T17:08:07Z   0 0 0900006485bb0f99
FDA-2022-N-2390-0021 FDA None FDA-2022-N-2390 Cover Memorandum to Commissioner RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing Supporting & Related Material Background Material 2023-06-22T04:00:00Z 2023 6     2023-06-22T14:42:10Z   0 0 0900006485bb01ea
FDA-2022-N-2390-0019 FDA None FDA-2022-N-2390 Vanda Scheduling Order Other Order 2023-05-25T04:00:00Z 2023 5 2023-05-25T04:00:00Z   2023-05-25T17:26:03Z   0 0 0900006485a613f6
FDA-2022-N-2390-0018 FDA None FDA-2022-N-2390 Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals, Inc to FDA CDER Other Letter(s) 2023-04-12T04:00:00Z 2023 4 2023-04-12T04:00:00Z   2023-04-12T17:21:59Z   0 0 090000648593604b
FDA-2022-N-2390-0017 FDA None FDA-2022-N-2390 Letter to Matthew Warren from FDA CDER Other Letter(s) 2023-02-21T05:00:00Z 2023 2 2023-02-21T05:00:00Z   2023-02-21T18:53:15Z   0 0 09000064856def37
FDA-2022-N-2390-0016 FDA None FDA-2022-N-2390 Vanda Submission Ex 032 (audio file) Other Record of Meeting/Phone Conversation 2023-01-20T05:00:00Z 2023 1 2023-01-20T05:00:00Z   2023-01-20T19:12:20Z   0 0 09000064855fce7d
FDA-2022-N-2390-0014 FDA None FDA-2022-N-2390 Letter from Vanda Pharmaceuticals, Inc to FDA CDER and FDA DMS Other Letter(s) 2023-01-10T05:00:00Z 2023 1 2023-01-10T05:00:00Z   2023-01-10T18:35:16Z   0 0 09000064855d315f
FDA-2022-N-2390-0015 FDA None FDA-2022-N-2390 Letter to Vanda Pharmaceuticals, Inc and FDA CDER Other Letter(s) 2023-01-10T05:00:00Z 2023 1 2023-01-10T05:00:00Z   2023-01-10T18:35:27Z   0 0 09000064855d315d

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options:

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;
Powered by Datasette · Queries took 1142.871ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API