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

6 rows where docket_id = "FDA-2019-D-5473" sorted by posted_date descending

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

posted_year 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-D-5473-0029 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry Other Guidance 2025-12-10T05:00:00Z 2025 12 2025-12-10T05:00:00Z   2025-12-10T20:21:24Z   1 0 09000064b90c20c5
FDA-2019-D-5473-0028 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2025-12-10T05:00:00Z 2025 12     2025-12-10T20:21:09Z 2025-22427 0 0 09000064b90c159b
FDA-2019-D-5473-0016 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2024-04-25T04:00:00Z 2024 4     2024-04-25T13:30:21Z 2024-08886 0 0 09000064864ee605
FDA-2019-D-5473-0017 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry; Revised Draft Guidance Other Guidance 2024-04-25T04:00:00Z 2024 4 2024-04-25T04:00:00Z 2024-06-25T03:59:59Z 2025-12-10T20:21:36Z   0 0 09000064864ee8bc
FDA-2019-D-5473-0002 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry Other Guidance 2020-02-04T05:00:00Z 2020 2 2020-02-04T05:00:00Z 2020-04-07T03:59:59Z 2024-04-25T13:29:55Z   0 0 0900006484325d68
FDA-2019-D-5473-0001 FDA None FDA-2019-D-5473 Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-02-04T05:00:00Z 2020 2 2020-02-04T05:00:00Z 2020-04-07T03:59:59Z 2020-02-23T21:50:39Z 2020-02100 0 0 0900006484325636

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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;