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-2009-D-0539" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-D-0539-0054 FDA None FDA-2009-D-0539 Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability Notice Notice of Availability 2019-02-01T05:00:00Z 2019 2 2019-02-01T05:00:00Z   2019-02-01T14:56:05Z 2019-00666 0 0 0900006483a32a52
FDA-2009-D-0539-0055 FDA None FDA-2009-D-0539 Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability Other Guidance 2019-02-01T05:00:00Z 2019 2 2019-02-01T05:00:00Z   2024-11-12T22:54:51Z   1 0 0900006483a33009
FDA-2009-D-0539-0024 FDA None FDA-2009-D-0539 Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products Guidance for Industry Other Guidance 2016-04-26T04:00:00Z 2016 4 2016-04-26T04:00:00Z   2019-06-18T16:22:13Z   0 0 0900006481f902a5
FDA-2009-D-0539-0023 FDA None FDA-2009-D-0539 Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2016-04-25T04:00:00Z 2016 4 2016-04-25T04:00:00Z 2016-06-25T03:59:59Z 2016-06-25T13:00:11Z 2016-09449 0 0 0900006481f89040
FDA-2009-D-0539-0002 FDA None FDA-2009-D-0539 Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins; Guidance Other Guidance 2009-12-04T05:00:00Z 2009 12 2009-12-04T05:00:00Z 2010-02-03T04:59:59Z 2016-04-11T14:26:47Z   0 0 0900006480a6350f
FDA-2009-D-0539-0001 FDA None FDA-2009-D-0539 Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability Notice Notice of Availability 2009-12-04T05:00:00Z 2009 12 2009-12-04T05:00:00Z 2010-02-03T04:59:59Z 2016-04-11T14:24:08Z E9-28960 0 0 0900006480a62b67

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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;