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

8 rows where docket_id = "FDA-2011-D-0605" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0605-0060 FDA None FDA-2011-D-0605 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry Other Guidance 2025-11-20T05:00:00Z 2025 11 2025-11-20T05:00:00Z 2026-01-21T04:59:59Z 2026-01-24T13:16:32Z   1 0 09000064b9088de2
FDA-2011-D-0605-0059 FDA None FDA-2011-D-0605 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability Notice Notice of Availability 2025-11-20T05:00:00Z 2025 11 2025-11-20T05:00:00Z   2025-11-20T19:15:15Z 2025-20380 0 0 09000064b908a856
FDA-2011-D-0605-0054 FDA None FDA-2011-D-0605 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry; Availability Notice Notice of Availability 2015-04-30T04:00:00Z 2015 4 2015-04-30T04:00:00Z   2025-11-20T19:18:14Z 2015-10062 0 0 0900006481ac4844
FDA-2011-D-0605-0055 FDA None FDA-2011-D-0605 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry Other Guidance 2015-04-28T04:00:00Z 2015 4 2015-04-28T04:00:00Z   2025-11-05T10:00:14Z   1 0 0900006481ac5991
FDA-2011-D-0605-0053 FDA None FDA-2011-D-0605 See FDA-2011-D-0618-0068 Supporting & Related Material   2012-05-31T00:00:00Z 2012 5     2012-06-01T15:50:21Z   0 1 090000648101d5c2
FDA-2011-D-0605-0033 FDA None FDA-2011-D-0605 Merck & Co., Inc. - Comment re FDA-2011-D-0605-0032 Supporting & Related Material Reference (external attachments) 2012-04-16T04:00:00Z 2012 4     2012-04-16T20:55:45Z   0 0 0900006480ff1e76
FDA-2011-D-0605-0002 FDA None FDA-2011-D-0605 Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to Reference Product Other Guidance 2012-02-15T05:00:00Z 2012 2 2012-02-15T05:00:00Z   2019-06-18T15:48:59Z   0 0 0900006480fb703a
FDA-2011-D-0605-0001 FDA None FDA-2011-D-0605 Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to Reference Product Notice Notice of Availability 2012-02-15T05:00:00Z 2012 2 2012-02-15T05:00:00Z 2012-04-17T03:59:59Z 2012-05-10T12:01:59Z 2012-03552 0 0 0900006480fb721e

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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;