documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
13 rows where docket_id = "FDA-2019-E-3278" sorted by posted_date descending
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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), comment_end_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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2019-E-3278-0012 | FDA | None FDA-2019-E-3278 | Notice of Final Determination | Other | Letter(s) | 2024-03-22T04:00:00Z | 2024 | 3 | 2024-03-22T04:00:00Z | 2024-03-22T17:47:43Z | 0 | 0 | 090000648648caf1 | ||
| FDA-2019-E-3278-0013 | FDA | None FDA-2019-E-3278 | Response to Request for Information Pursuant to 37 C.F.R. 1.750 | Other | Letter(s) | 2024-03-14T04:00:00Z | 2024 | 3 | 2024-09-18T04:00:00Z | 2024-09-18T18:42:43Z | 0 | 0 | 090000648648cbb3 | ||
| FDA-2019-E-3278-0011 | FDA | None FDA-2019-E-3278 | Letter to U.S. Patent and Trademark Office | Other | Letter(s) | 2024-03-13T04:00:00Z | 2024 | 3 | 2024-03-13T04:00:00Z | 2024-03-13T17:59:00Z | 0 | 0 | 09000064864795a4 | ||
| FDA-2019-E-3278-0010 | FDA | None FDA-2019-E-3278 | Requirement for Information Letter from U.S. Patent and Trademark Office to Merck & Co. Inc. | Other | Letter(s) | 2024-02-28T05:00:00Z | 2024 | 2 | 2024-02-28T05:00:00Z | 2024-03-13T17:52:22Z | 0 | 0 | 090000648641eab3 | ||
| FDA-2019-E-3278-0009 | FDA | None FDA-2019-E-3278 | Letter from U.S. Patent and Trademark Office to FDA CDER | Other | Letter(s) | 2024-01-10T05:00:00Z | 2024 | 1 | 2024-01-10T05:00:00Z | 2024-03-13T17:52:04Z | 0 | 0 | 0900006486389509 | ||
| FDA-2019-E-3278-0008 | FDA | None FDA-2019-E-3278 | Determination of Regulatory Review Period for Purposes of Patent Extension; DELSTRIGO—New Drug Application 210807 | Notice | Determinations | 2023-08-04T04:00:00Z | 2023 | 8 | 2023-08-04T04:00:00Z | 2023-10-04T03:59:59Z | 2023-08-04T15:49:29Z | 2023-16606 | 0 | 0 | 0900006485dc5b38 |
| FDA-2019-E-3278-0007 | FDA | None FDA-2019-E-3278 | Determination of Regulatory Review Period for Purposes of Patent Extension; PIFELTRO—New Drug Application 210806 | Notice | Determinations | 2023-08-04T04:00:00Z | 2023 | 8 | 2023-08-04T04:00:00Z | 2023-10-04T03:59:59Z | 2023-08-04T15:49:17Z | 2023-16607 | 0 | 0 | 0900006485dbe4a8 |
| FDA-2019-E-3278-0005 | FDA | None FDA-2019-E-3278 | Letter from FDA CDER to U.S. Patent and Trademark Office | Other | Letter(s) | 2023-07-14T04:00:00Z | 2023 | 7 | 2023-07-14T04:00:00Z | 2023-07-14T18:55:02Z | 0 | 0 | 0900006485cb38f4 | ||
| FDA-2019-E-3278-0006 | FDA | None FDA-2019-E-3278 | Letter from FDA CDER to U.S. Patent and Trademark Office | Other | Letter(s) | 2023-07-14T04:00:00Z | 2023 | 7 | 2023-07-14T04:00:00Z | 2023-07-14T21:16:05Z | 0 | 0 | 0900006485cb551c | ||
| FDA-2019-E-3278-0004 | FDA | None FDA-2019-E-3278 | Letter from U.S. Patent and Trademark Office to FDA CDER | Other | Letter(s) | 2022-12-29T05:00:00Z | 2022 | 12 | 2022-12-29T05:00:00Z | 2022-12-29T21:26:33Z | 0 | 0 | 090000648555fb6a | ||
| FDA-2019-E-3278-0003 | FDA | None FDA-2019-E-3278 | Letter to U.S. Patent and Trademark Office from FDA CDER | Other | Letter(s) | 2019-12-02T05:00:00Z | 2019 | 12 | 2019-12-02T05:00:00Z | 2019-12-02T18:24:43Z | 0 | 0 | 09000064841d9231 | ||
| FDA-2019-E-3278-0002 | FDA | None FDA-2019-E-3278 | Patent Extension Application from Merk & Co., Inc. (on behalf of Merck Canada Inc.) | Other | Application | 2019-07-08T04:00:00Z | 2019 | 7 | 2019-07-08T04:00:00Z | 2019-07-09T12:45:15Z | 0 | 0 | 0900006483d6a50a | ||
| FDA-2019-E-3278-0001 | FDA | None FDA-2019-E-3278 | Letter from U.S. Patent and Trademark Office to FDA CDER | Other | Letter(s) | 2019-07-08T04:00:00Z | 2019 | 7 | 2019-07-08T04:00:00Z | 2019-07-08T19:57:00Z | 0 | 0 | 0900006483d6a509 |
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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;