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

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21 rows where docket_id = "FDA-2016-N-3464" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-3464-0029 FDA None FDA-2016-N-3464 List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act Rule Final Rule 2019-02-19T05:00:00Z 2019 2 2019-02-19T05:00:00Z   2019-02-19T14:46:18Z 2019-02367 0 0 0900006483a88bb0
FDA-2016-N-3464-0033 FDA None FDA-2016-N-3464 Reference 16 - Food and Drug Administration Supplemental Review of Topical Tranilast, April 25, 2016. Supporting & Related Material Background Material 2019-02-19T05:00:00Z 2019 2     2019-02-19T19:50:14Z   0 0 0900006483a8baf0
FDA-2016-N-3464-0030 FDA None FDA-2016-N-3464 Reference 3 - Memorandum to File on Food and Drug Administration Consultations with United States Pharmacopeia, September 26, 2016. Supporting & Related Material Background Material 2019-02-19T05:00:00Z 2019 2     2019-02-19T19:44:10Z   0 0 0900006483a8baed
FDA-2016-N-3464-0031 FDA None FDA-2016-N-3464 Reference 4 - Letter from the United States Pharmacopeia to FDA, October 7, 2016. Supporting & Related Material Background Material 2019-02-19T05:00:00Z 2019 2     2019-02-19T19:46:13Z   0 0 0900006483a8baee
FDA-2016-N-3464-0032 FDA None FDA-2016-N-3464 Reference 10 - Food and Drug Administration Supplemental Review of Oxitriptan, November 2018. Supporting & Related Material Background Material 2019-02-19T05:00:00Z 2019 2     2019-02-19T19:48:01Z   0 0 0900006483a8baef
FDA-2016-N-3464-0005 FDA None FDA-2016-N-3464 Reference 3 - FDA, Transcript of the February 24, 2015, Meeting of the Pharmacy Compounding Advisory Committee, 2015 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:35Z   0 0 0900006482415bee
FDA-2016-N-3464-0008 FDA None FDA-2016-N-3464 Reference 6 - Letter from USP to FDA, October 7, 2016 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:45Z   0 0 0900006482415e69
FDA-2016-N-3464-0004 FDA None FDA-2016-N-3464 Reference 2 - FDA, Transcript of the February 23, 2015, Meeting of the Pharmacy Compounding Advisory Committee (Afternoon Session), 2015 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:31Z   0 0 0900006482415bed
FDA-2016-N-3464-0007 FDA None FDA-2016-N-3464 Reference 5 - Memorandum to File on FDA Consultations with USP, September 26, 2016 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:42Z   0 0 0900006482415e68
FDA-2016-N-3464-0002 FDA None FDA-2016-N-3464 References List for FDA-2016-N-3464 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:18Z   0 0 0900006482415beb
FDA-2016-N-3464-0003 FDA None FDA-2016-N-3464 Reference 1 - Guidance for Industry Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:27Z   0 0 0900006482415bec
FDA-2016-N-3464-0012 FDA None FDA-2016-N-3464 Reference 10 - Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:59Z   0 0 0900006482415e6d
FDA-2016-N-3464-0015 FDA None FDA-2016-N-3464 Reference 13 - Case Series The Effectiveness of Fatty Acids From Pracaxi Oil in a Topical Silicone Base for Scar and Wound Therapy Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:13:09Z   0 0 0900006482415e70
FDA-2016-N-3464-0010 FDA None FDA-2016-N-3464 Reference 8 - FDA Briefing Document for the February 23-24, 2015, Meeting of the Pharmacy Compounding Advisory Committee, 2015 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:52Z   0 0 0900006482415e6b
FDA-2016-N-3464-0009 FDA None FDA-2016-N-3464 Reference 7 - FDA Briefing Document for the June 17-18, 2015, Meeting of the Pharmacy Compounding Advisory Committee, 2015 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:49Z   0 0 0900006482415e6a
FDA-2016-N-3464-0001 FDA None FDA-2016-N-3464 List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-12-16T05:00:00Z 2016 12 2016-12-16T05:00:00Z 2017-03-17T03:59:59Z 2017-08-05T01:02:50Z 2016-30109 0 0 090000648241437d
FDA-2016-N-3464-0011 FDA None FDA-2016-N-3464 Reference 9 - Piracetam in the Treatment of Different Types of Myoclonus Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:56Z   0 0 0900006482415e6c
FDA-2016-N-3464-0006 FDA None FDA-2016-N-3464 Reference 4 - Transcript of the June 17, 2015, Meeting of the Pharmacy Compounding Advisory Committee (Afternoon Session), 2015 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:12:39Z   0 0 0900006482415bef
FDA-2016-N-3464-0013 FDA None FDA-2016-N-3464 Reference 11 - FDA Supplemental Review of Topical Tranilast, April 25, 2016 Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:13:02Z   0 0 0900006482415e6e
FDA-2016-N-3464-0014 FDA None FDA-2016-N-3464 Reference 12 - Treatment of Keloid and Hypertrophic Scars by Iontophoretic Transdermal Delivery of Tranilast Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2016-12-16T16:13:06Z   0 0 0900006482415e6f
FDA-2016-N-3464-0016 FDA None FDA-2016-N-3464 Reference 14 - Economic Analysis of Impacts Supporting & Related Material Background Material 2016-12-16T05:00:00Z 2016 12     2017-06-06T19:09:42Z   0 0 0900006482415e71

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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;