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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

8 rows where docket_id = "FDA-2008-D-0626" 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Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 3

  • Supporting & Related Material 4
  • Notice 2
  • Other 2

posted_year 2

  • 2008 5
  • 2009 3

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-D-0626-0032 FDA None FDA-2008-D-0626 See FDA-2008-D-0626-0034 Supporting & Related Material C-Comment (Supporting and Related Material) 2009-08-20T04:00:00Z 2009 8     2012-03-24T19:34:47Z   0 0 0900006480a0debe
FDA-2008-D-0626-0033 FDA None FDA-2008-D-0626 See FDA-2009-D-0626-0034 Supporting & Related Material   2009-08-20T00:00:00Z 2009 8     2012-03-24T19:36:37Z   0 1 0900006480a04768
FDA-2008-D-0626-0012 FDA None FDA-2008-D-0626 Draft Guidance for Industry: Bioequivalence Recommendation for Vancomycin HCl; Extension of Comment Period Notice NEC-Notice of Extension 2009-02-10T05:00:00Z 2009 2 2009-02-10T05:00:00Z 2009-03-20T03:59:59Z 2009-02-10T21:34:33Z E9-02800 0 0 090000648084faeb
FDA-2008-D-0626-0005 FDA None FDA-2008-D-0626 ViroPharma Incorporated - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2008-12-22T05:00:00Z 2008 12 2008-12-22T05:00:00Z   2013-07-27T22:34:03Z   0 0 09000064807e36f0
FDA-2008-D-0626-0002 FDA None FDA-2008-D-0626 Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Guidance Other GDL-Guidance (Supporting and Related Materials) 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z   2024-11-12T04:26:03Z   1 0 09000064807ddb4a
FDA-2008-D-0626-0001 FDA None FDA-2008-D-0626 Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z 2009-02-18T04:59:59Z 2009-01-23T17:39:34Z E8-29692 0 0 09000064807dd7fc
FDA-2008-D-0626-0003 FDA None FDA-2008-D-0626 Report to Office of Generic Drugs - "Vancomycin Solubility Study" - [Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Guidance] re FDA-2008-D-0626-0002 - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-16T05:00:00Z 2008 12     2010-11-03T16:20:46Z   0 0 09000064807ddb61
FDA-2008-D-0626-0004 FDA None FDA-2008-D-0626 Report to Office of Generic Drugs - "Vancomycin Dissolution Study" - [Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Guidance] re FDA-2008-D-0626-0002 - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-16T05:00:00Z 2008 12     2010-11-03T16:24:23Z   0 0 09000064807ddb72

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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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