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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

7 rows where docket_id = "FDA-2017-D-5767" sorted by posted_date descending

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Suggested facets: title, 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 2

  • 2017 5
  • 2021 2

document_type 2

  • Other 4
  • Notice 3

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-D-5767-0029 FDA None FDA-2017-D-5767 ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry Other Guidance 2021-05-20T04:00:00Z 2021 5 2021-05-20T04:00:00Z   2024-11-06T23:47:57Z   1 0 0900006484b23f31
FDA-2017-D-5767-0028 FDA None FDA-2017-D-5767 Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability Notice Notice of Availability 2021-05-20T04:00:00Z 2021 5 2021-05-20T04:00:00Z   2021-05-25T13:29:16Z 2021-10603 0 0 0900006484b235e6
FDA-2017-D-5767-0021 FDA None FDA-2017-D-5767 Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period Notice Notice of Availability 2017-12-08T05:00:00Z 2017 12 2017-12-08T05:00:00Z 2018-02-05T04:59:59Z 2018-02-03T02:04:56Z 2017-26436 0 0 0900006482cf2a7a
FDA-2017-D-5767-0022 FDA None FDA-2017-D-5767 ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry DRAFT GUIDANCE Other Guidance 2017-12-08T05:00:00Z 2017 12 2017-12-08T05:00:00Z 2018-02-05T04:59:59Z 2019-06-18T16:11:51Z   0 0 0900006482cf3aff
FDA-2017-D-5767-0016 FDA None FDA-2017-D-5767 Request for Extension for United States Pharmacopeia (USP) Other Request for Extension 2017-12-04T05:00:00Z 2017 12 2017-10-03T04:00:00Z 2017-12-05T04:59:59Z 2017-12-04T21:56:11Z   0 0 0900006482cd6122
FDA-2017-D-5767-0001 FDA None FDA-2017-D-5767 Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-10-03T04:00:00Z 2017 10 2017-10-03T04:00:00Z 2017-12-05T04:59:59Z 2017-12-05T02:04:00Z 2017-21202 0 0 0900006482b9376f
FDA-2017-D-5767-0002 FDA None FDA-2017-D-5767 ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry DRAFT GUIDANCE Other Guidance 2017-10-03T04:00:00Z 2017 10 2017-10-03T04:00:00Z 2017-12-05T04:59:59Z 2024-11-07T01:17:03Z   1 0 0900006482b94e60

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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;
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