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

11 rows where docket_id = "FDA-2010-D-0482" sorted by posted_date descending

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posted_year 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-D-0482-0033 FDA None FDA-2010-D-0482 Guidances for Industry and Investigators; on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/ Bioequivalence Studies, and a Small Entity Compliance Guide; Availability Notice Notice of Availability 2012-12-20T05:00:00Z 2012 12 2012-12-20T05:00:00Z   2019-08-22T20:02:45Z 2012-30651 0 0 0900006481193abb
FDA-2010-D-0482-0034 FDA None FDA-2010-D-0482 Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA BE Studies Other Guidance 2012-12-20T05:00:00Z 2012 12 2012-12-20T05:00:00Z   2024-11-12T05:10:37Z   1 0 0900006481193beb
FDA-2010-D-0482-0035 FDA None FDA-2010-D-0482 Guidances for Industry and Investigators; on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/ Bioequivalence Studies, Small Entity Compliance Guide Other Guidance 2012-12-20T05:00:00Z 2012 12 2012-12-20T05:00:00Z   2019-08-22T20:06:38Z   0 0 0900006481193bed
FDA-2010-D-0482-0032 FDA None FDA-2010-D-0482 Minute of the FDA-PhRMA Dialogue, dated September 9, 2011 Other Minutes 2012-04-13T04:00:00Z 2012 4 2012-04-13T04:00:00Z   2019-08-22T20:02:30Z   0 0 0900006480feea00
FDA-2010-D-0482-0029 FDA None FDA-2010-D-0482 Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability Notice NAD-Notice of Availability of Data 2011-06-07T04:00:00Z 2011 6 2011-06-07T04:00:00Z   2011-06-07T15:38:14Z 2011-13950 0 0 0900006480e3df14
FDA-2010-D-0482-0030 FDA None FDA-2010-D-0482 Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: Investigational New Drug Applications and Bioavailability/Bioequivalence Studies Other GDL-Guidance 2011-06-07T04:00:00Z 2011 6 2011-06-07T04:00:00Z   2019-08-22T20:03:09Z   0 0 0900006480e3e2a5
FDA-2010-D-0482-0027 FDA None FDA-2010-D-0482 FDA/PhRMA Meeting Minutes Other MM-Memorandum of Meeting 2011-05-05T04:00:00Z 2011 5 2011-05-05T04:00:00Z   2013-07-27T23:52:13Z   0 0 0900006480c40227
FDA-2010-D-0482-0026 FDA None FDA-2010-D-0482 Pharmaceutical Research and Manufacturers of America (PhRMA) - Letter Other LET-Letter 2011-05-05T04:00:00Z 2011 5 2011-05-05T04:00:00Z   2013-07-27T23:52:13Z   0 0 0900006480c40225
FDA-2010-D-0482-0025 FDA None FDA-2010-D-0482 New IND Safety Reporting Requirements Supporting & Related Material N-Notice (Supporting and Related Material) 2011-03-28T04:00:00Z 2011 3     2011-03-28T13:20:19Z   0 0 0900006480c11d39
FDA-2010-D-0482-0020 FDA None FDA-2010-D-0482 Safety Reporting Requirements for INDs and BA/BE Studies; Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2011-01-21T05:00:00Z 2011 1 2011-01-21T05:00:00Z   2017-12-06T02:02:21Z   0 0 0900006480b63418
FDA-2010-D-0482-0001 FDA None FDA-2010-D-0482 Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability Notice GDL-Guidance 2010-09-29T04:00:00Z 2010 9 2010-09-29T04:00:00Z 2010-12-29T04:59:59Z 2010-09-29T15:28:33Z 2010-24295 0 0 0900006480b63098

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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;