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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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