documents
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
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)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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
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;