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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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13 rows where docket_id = "FDA-2007-D-0369" and posted_year = 2016 sorted by posted_date descending

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document_type 3

  • Notice 11
  • Other 1
  • Supporting & Related Material 1

posted_year 1

  • 2016 · 13 ✖

agency_id 1

  • FDA 13
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0369-0399 FDA None FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-12-23T05:00:00Z 2016 12 2016-12-23T05:00:00Z 2017-02-22T04:59:59Z 2017-03-08T02:01:43Z 2016-30984 0 0 09000064824338b3
FDA-2007-D-0369-0397 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2016-11-25T05:00:00Z 2016 11 2016-11-25T05:00:00Z 2017-01-25T04:59:59Z 2016-11-25T14:45:56Z 2016-28334 0 0 09000064823beea5
FDA-2007-D-0369-0392 FDA None FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-10-05T04:00:00Z 2016 10 2016-10-05T04:00:00Z 2016-12-06T04:59:59Z 2016-12-06T14:04:42Z 2016-24050 0 0 090000648229a04c
FDA-2007-D-0369-0390 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability Notice Guidance 2016-08-30T04:00:00Z 2016 8 2016-08-30T04:00:00Z 2016-11-01T03:59:59Z 2016-11-01T01:01:58Z 2016-20778 0 0 09000064821ae192
FDA-2007-D-0369-0389 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-08-24T04:00:00Z 2016 8 2016-08-24T04:00:00Z   2016-08-24T14:28:13Z 2016-20146 0 0 090000648219797c
FDA-2007-D-0369-0387 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-07-01T04:00:00Z 2016 7 2016-07-01T04:00:00Z 2016-09-07T03:59:59Z 2024-11-12T06:09:25Z 2016-15663 1 0 090000648208058a
FDA-2007-D-0369-0386 FDA None FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-06-17T04:00:00Z 2016 6 2016-06-17T04:00:00Z 2016-08-17T03:59:59Z 2016-06-17T14:20:19Z 2016-14351 0 0 090000648204af5a
FDA-2007-D-0369-0379 FDA None FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-04-15T04:00:00Z 2016 4 2016-04-15T04:00:00Z   2024-11-07T23:45:39Z 2016-08682 1 0 0900006481f6c060
FDA-2007-D-0369-0377 FDA None FDA-2007-D-0369 Supplement from Janssen Research & Development, LLC Other Supplement (SUP) 2016-03-02T05:00:00Z 2016 3 2016-03-02T05:00:00Z   2016-03-02T17:01:54Z   0 0 0900006481e88283
FDA-2007-D-0369-0376 FDA None FDA-2007-D-0369 Supplemental Comment from GlaxoSmithKline Supporting & Related Material Background Material 2016-02-19T05:00:00Z 2016 2     2016-02-19T19:50:20Z   0 0 0900006481e7873d
FDA-2007-D-0369-0375 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-02-16T05:00:00Z 2016 2 2016-02-16T05:00:00Z 2016-04-19T03:59:59Z 2016-04-19T03:00:38Z 2016-02975 0 0 0900006481e6e395
FDA-2007-D-0369-0372 FDA None FDA-2007-D-0369 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2016-01-28T05:00:00Z 2016 1 2016-01-28T05:00:00Z   2024-11-12T05:55:26Z 2016-01682 1 0 0900006481e35c6a
FDA-2007-D-0369-0373 FDA None FDA-2007-D-0369 Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-01-28T05:00:00Z 2016 1 2016-01-28T05:00:00Z 2016-03-29T03:59:59Z 2016-01-28T17:08:30Z 2016-01683 0 0 0900006481e35ca7

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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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