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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

2 rows where docket_id = "FDA-2004-D-0353" sorted by posted_date descending

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Suggested facets: posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 2

  • Notice 1
  • Supporting & Related Material 1

posted_year 1

  • 2004 2

agency_id 1

  • FDA 2
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-D-0353-0001 FDA Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) FDA-2004-D-0353 FDA Notice NAD-Notice of Availability of Data 2004-11-10T05:00:00Z 2004 11 2004-11-08T05:00:00Z 2005-02-08T04:59:59Z 2008-04-12T00:35:51Z   0 0 090000648047353d
FDA-2004-D-0353-0002 FDA Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) FDA-2004-D-0353 Guidance Supporting & Related Material GDL-Guidance 2004-11-10T05:00:00Z 2004 11     2008-04-12T00:35:51Z   0 0 0900006480473541

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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    withdrawn INTEGER,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);
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