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

2 rows where docket_id = "FDA-1995-D-0288" and posted_year = 2018 sorted by posted_date descending

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posted_year 1

  • 2018 · 2 ✖

document_type 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1995-D-0288-0030 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2018-01-04T05:00:00Z 2018 1     2018-01-04T14:41:50Z   0 0 0900006482d96265
FDA-1995-D-0288-0031 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2018-01-04T05:00:00Z 2018 1     2018-01-04T14:41:58Z   0 0 0900006482d962c0

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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    withdrawn INTEGER,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);