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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

9 rows where docket_id = "FDA-2009-D-0386" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2009 3
  • 2011 2
  • 2015 2
  • 2017 2

document_type 3

  • Notice 4
  • Other 4
  • Supporting & Related Material 1

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0386-0016 FDA None FDA-2009-D-0386 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2017-09-15T04:00:00Z 2017 9 2017-09-15T04:00:00Z   2017-09-15T14:44:44Z 2017-19612 0 0 0900006482b3afbe
FDA-2009-D-0386-0017 FDA None FDA-2009-D-0386 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2017-09-15T04:00:00Z 2017 9 2017-09-15T04:00:00Z   2024-11-07T01:11:07Z   1 0 0900006482b3c560
FDA-2009-D-0386-0012 FDA None FDA-2009-D-0386 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses Draft Guidance for Industry and Food and Drug Administration Staff Other Guidance 2015-08-14T04:00:00Z 2015 8 2015-08-14T04:00:00Z   2024-11-12T05:41:28Z   1 0 0900006481c20f52
FDA-2009-D-0386-0011 FDA None FDA-2009-D-0386 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability Notice Notice of Availability 2015-08-14T04:00:00Z 2015 8 2015-08-14T04:00:00Z 2015-11-13T04:59:59Z 2015-11-07T02:30:53Z 2015-19983 0 0 0900006481c206a6
FDA-2009-D-0386-0010 FDA None FDA-2009-D-0386 Guidance for Industry and Staff; Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses Other Guidance 2011-11-28T05:00:00Z 2011 11 2011-11-28T05:00:00Z   2015-07-29T16:44:57Z   0 0 0900006480f7483f
FDA-2009-D-0386-0009 FDA None FDA-2009-D-0386 Guidance for Industry and Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses Notice Notice of Availability 2011-11-28T05:00:00Z 2011 11 2011-11-28T05:00:00Z   2015-07-29T16:44:35Z 2011-30552 0 0 0900006480f743be
FDA-2009-D-0386-0005 FDA None FDA-2009-D-0386 Enclosure - "Lee, et al., Signature Sequence Validation of Human Papillomavirus" - [Sin Hang Lee, MD (Milford Hospital) - Comment] Supporting & Related Material   2009-11-05T00:00:00Z 2009 11     2009-11-06T01:34:42Z   0 1 0900006480a4f31c
FDA-2009-D-0386-0001 FDA None FDA-2009-D-0386 Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability Notice Notice of Availability 2009-09-09T04:00:00Z 2009 9 2009-09-09T04:00:00Z 2009-12-09T04:59:59Z 2015-07-29T16:43:45Z E9-21725 0 0 0900006480a1f23a
FDA-2009-D-0386-0002 FDA None FDA-2009-D-0386 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-09-09T04:00:00Z 2009 9 2009-09-09T04:00:00Z   2024-11-12T04:40:42Z   1 0 0900006480a1f52d

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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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