documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
- comment_end_date
- A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
- comment_start_date
- A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)
20 rows where docket_id = "FDA-2011-D-0611" sorted by posted_date descending
This data as json, CSV (advanced)
agency_id 1
- FDA 20
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2011-D-0611-0105 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry | Other | Guidance | 2026-10-15T04:00:00Z | 2026 | 10 | 2026-10-15T04:00:00Z | 2026-10-15T19:50:39Z | 1 | 0 | 09000064b9670307 | ||
| FDA-2011-D-0611-0093 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-03-10T04:00:00Z | 2026 | 3 | 2026-03-10T04:00:00Z | 2026-03-10T17:31:26Z | 2026-04664 | 0 | 0 | 09000064b9206be8 | |
| FDA-2011-D-0611-0095 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Questions and Answers on Biosimilar Development and the BPCI Act - Guidance for Industry | Other | Guidance | 2026-03-10T04:00:00Z | 2026 | 3 | 2026-03-10T04:00:00Z | 2026-05-12T09:00:11Z | 1 | 0 | 09000064b92071c6 | ||
| FDA-2011-D-0611-0094 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) Guidance for Industry - Draft Guidance | Other | Guidance | 2026-03-10T04:00:00Z | 2026 | 3 | 2026-03-10T04:00:00Z | 2026-05-12T03:59:59Z | 2026-05-12T09:00:11Z | 1 | 0 | 09000064b92071bb | |
| FDA-2011-D-0611-0091 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act; Guidance for Industry; Draft Guidance | Other | Guidance | 2023-09-15T00:00:00Z | 2023 | 9 | 2023-09-15T00:00:00Z | 2025-05-06T01:33:49Z | 1 | 0 | 0900006485fb1ea4 | ||
| FDA-2011-D-0611-0089 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Final Guidance Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry | Other | Guidance | 2021-09-20T04:00:00Z | 2021 | 9 | 2021-09-20T04:00:00Z | 2021-09-20T15:02:28Z | 0 | 0 | 0900006484d94970 | ||
| FDA-2011-D-0611-0088 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Questions and Answers on BiosimilarDevelopment and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability | Notice | Notice of Availability | 2021-09-20T04:00:00Z | 2021 | 9 | 2021-09-20T04:00:00Z | 2021-09-21T00:59:26Z | 2021-20255 | 0 | 0 | 0900006484d93980 | |
| FDA-2011-D-0611-0082 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry | Other | Guidance | 2020-11-20T05:00:00Z | 2020 | 11 | 2020-11-20T05:00:00Z | 2024-11-06T23:43:39Z | 1 | 0 | 090000648496c7ea | ||
| FDA-2011-D-0611-0081 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2020-11-20T05:00:00Z | 2020 | 11 | 2020-11-20T05:00:00Z | 2021-01-20T04:59:59Z | 2021-01-21T02:00:45Z | 2020-25606 | 0 | 0 | 090000648496ac54 |
| FDA-2011-D-0611-0080 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Memorandum of Meeting to Discuss Post-Licensure Biosimilar Labeling Changes | Other | Memorandum | 2019-07-18T04:00:00Z | 2019 | 7 | 2019-07-18T04:00:00Z | 2019-07-18T15:21:39Z | 0 | 0 | 0900006483d9d811 | ||
| FDA-2011-D-0611-0065 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2018-12-12T05:00:00Z | 2018 | 12 | 2018-12-12T05:00:00Z | 2019-02-12T04:59:59Z | 2019-11-18T16:51:35Z | 2018-26852 | 0 | 0 | 0900006483987c81 |
| FDA-2011-D-0611-0064 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability | Notice | Notice of Availability | 2018-12-12T05:00:00Z | 2018 | 12 | 2018-12-12T05:00:00Z | 2018-12-12T15:04:52Z | 2018-26853 | 0 | 0 | 0900006483987c7c | |
| FDA-2011-D-0611-0067 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry | Other | Guidance | 2018-12-11T05:00:00Z | 2018 | 12 | 2018-12-11T05:00:00Z | 2024-11-12T22:53:26Z | 1 | 0 | 0900006483988a7d | ||
| FDA-2011-D-0611-0066 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2); Guidance for Industry; Draft Guidance | Other | Guidance | 2018-12-11T05:00:00Z | 2018 | 12 | 2018-12-11T05:00:00Z | 2024-11-12T22:53:26Z | 1 | 0 | 0900006483988a81 | ||
| FDA-2011-D-0611-0056 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry | Other | Guidance | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T04:00:00Z | 2019-11-18T16:53:10Z | 0 | 0 | 0900006481addc66 | ||
| FDA-2011-D-0611-0055 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2015-05-13T04:00:00Z | 2015 | 5 | 2015-05-13T04:00:00Z | 2015-07-14T03:59:59Z | 2015-07-14T01:30:24Z | 2015-11528 | 0 | 0 | 0900006481addda4 |
| FDA-2011-D-0611-0054 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry | Other | Guidance | 2015-04-30T04:00:00Z | 2015 | 4 | 2015-04-30T04:00:00Z | 2019-11-18T16:52:55Z | 0 | 0 | 0900006481ac56a1 | ||
| FDA-2011-D-0611-0053 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability | Notice | Notice of Availability | 2015-04-30T04:00:00Z | 2015 | 4 | 2015-04-30T04:00:00Z | 2015-04-30T15:38:03Z | 2015-10064 | 0 | 0 | 0900006481ac4d35 | |
| FDA-2011-D-0611-0001 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability | Notice | Notice of Availability | 2012-02-15T05:00:00Z | 2012 | 2 | 2012-02-15T05:00:00Z | 2012-04-17T03:59:59Z | 2012-05-12T12:01:36Z | 2012-03549 | 0 | 0 | 0900006480fb722f |
| FDA-2011-D-0611-0002 | FDA | Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 FDA-2011-D-0611 | Guidance for Industry on Implementation of Biologics Price Competition and Innovation Act of 2009; Draft Guidance | Other | Guidance | 2012-02-15T05:00:00Z | 2012 | 2 | 2012-02-15T05:00:00Z | 2019-11-18T16:52:17Z | 0 | 0 | 0900006480fb7017 |
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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;