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

10 rows where docket_id = "FDA-2007-D-0369" and posted_year = 2014 sorted by posted_date descending

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

posted_year 1

  • 2014 · 10 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-D-0369-0310 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product Specific Bioequivalence Recommendations Availability Notice Notice of Availability 2014-12-30T05:00:00Z 2014 12 2014-12-30T05:00:00Z 2015-03-03T04:59:59Z 2024-11-12T05:29:27Z 2014-30514 1 0 0900006481999bc7
FDA-2007-D-0369-0309 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-24T05:00:00Z 2014 12 2014-12-24T05:00:00Z 2015-02-24T04:59:59Z 2015-02-24T03:14:02Z 2014-30109 0 0 09000064819910d4
FDA-2007-D-0369-0308 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-12-11T05:00:00Z 2014 12 2014-12-11T05:00:00Z 2015-02-10T04:59:59Z 2015-02-10T03:01:55Z 2014-29035 0 0 090000648196d9d1
FDA-2007-D-0369-0298 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-11-06T05:00:00Z 2014 11 2014-11-06T05:00:00Z 2015-01-06T04:59:59Z 2015-01-07T03:02:51Z 2014-26306 0 0 090000648191ac5d
FDA-2007-D-0369-0297 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability Notice Notice of Availability 2014-09-22T04:00:00Z 2014 9 2014-09-22T04:00:00Z 2014-11-22T04:59:59Z 2014-09-22T15:04:24Z 2014-22450 0 0 0900006481885a9f
FDA-2007-D-0369-0296 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2014-07-23T04:00:00Z 2014 7 2014-07-23T04:00:00Z 2014-09-23T03:59:59Z 2014-09-18T01:03:32Z 2014-17293 0 0 09000064817d75b7
FDA-2007-D-0369-0292 FDA None FDA-2007-D-0369 Attachment 1 List of Attachments re Comment from Alkermes Inc Supporting & Related Material Background Material 2014-06-20T04:00:00Z 2014 6     2014-11-04T16:39:57Z   0 0 0900006481734fe8
FDA-2007-D-0369-0294 FDA None FDA-2007-D-0369 Tab 1 FDA Draft Guidance on Naltrexone re Comment from Alkermes Inc Supporting & Related Material Background Material 2014-06-20T04:00:00Z 2014 6     2014-11-04T16:45:18Z   0 0 09000064817355c1
FDA-2007-D-0369-0293 FDA None FDA-2007-D-0369 Attachment 2 Appendix re Comment from Alkermes Inc Supporting & Related Material Background Material 2014-06-20T04:00:00Z 2014 6     2014-11-04T16:41:04Z   0 0 0900006481734fea
FDA-2007-D-0369-0290 FDA None FDA-2007-D-0369 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice Notice of Availability 2014-04-02T04:00:00Z 2014 4 2014-04-02T04:00:00Z 2014-06-03T03:59:59Z 2014-11-27T03:01:03Z 2014-07330 0 0 0900006481697913

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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;