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

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16 rows where docket_id = "FDA-2011-D-0611" sorted by posted_date descending

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

posted_year 7

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0611-0091 FDA None 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and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act; Guidance for Industry; Draft Guidance Other Guidance 2023-09-15T00:00:00Z 2023 9 2023-09-15T00:00:00Z   2025-05-06T01:33:49Z   1 0 0900006485fb1ea4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 None 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 None 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 None 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 None 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Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z 2021-01-20T04:59:59Z 2021-01-21T02:00:45Z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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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;