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withdrawn,object_id FDA-2019-E-3295-0010,FDA,FDA-2019-E-3295,Notice of Final Determination and Requirement for Election,Other,Letter(s),2024-03-18T04:00:00Z,2024,3,2024-03-18T04:00:00Z,,2024-03-18T19:18:22Z,,0,0,090000648648250a FDA-2019-E-3295-0009,FDA,FDA-2019-E-3295,Requirement for Information Letter,Other,Letter(s),2024-03-07T05:00:00Z,2024,3,2024-03-07T05:00:00Z,,2024-03-07T18:44:56Z,,0,0,09000064864218fd FDA-2019-E-3295-0008,FDA,FDA-2019-E-3295,Letter from FDA CDER to U.S. Patent and Trademark Office,Other,Letter(s),2024-02-05T05:00:00Z,2024,2,2024-02-05T05:00:00Z,,2024-02-05T20:45:01Z,,0,0,09000064863e5a31 FDA-2019-E-3295-0007,FDA,FDA-2019-E-3295,Letter from U. S. Patent and Trademark Office to FDA CDER,Other,Letter(s),2024-01-17T05:00:00Z,2024,1,2024-01-17T05:00:00Z,,2024-01-17T19:16:38Z,,0,0,090000648638f7da FDA-2019-E-3295-0006,FDA,FDA-2019-E-3295,Determination of Regulatory Review Period for Purposes of Patent Extension; GALAFOLD,Notice,Determinations,2023-03-22T04:00:00Z,2023,3,2023-03-22T04:00:00Z,2023-05-23T03:59:59Z,2023-03-22T15:03:36Z,2023-05897,0,0,09000064858232a2 FDA-2019-E-3295-0005,FDA,FDA-2019-E-3295,Letter from FDA CDER to U.S. Patent and Trademark Office,Other,Letter(s),2023-03-09T05:00:00Z,2023,3,2023-03-09T05:00:00Z,,2023-03-09T19:48:33Z,,0,0,09000064857854f7 FDA-2019-E-3295-0004,FDA,FDA-2019-E-3295,Letter from U.S. Patent and Trademark Office to FDA CDER,Other,Letter(s),2022-12-29T05:00:00Z,2022,12,2022-12-29T05:00:00Z,,2022-12-29T21:19:09Z,,0,0,090000648555f839 FDA-2019-E-3295-0003,FDA,FDA-2019-E-3295,Letter to U.S. Patent and Trademark Office from FDA CDER,Other,Letter(s),2019-10-29T04:00:00Z,2019,10,2019-10-29T04:00:00Z,,2019-10-29T20:13:20Z,,0,0,0900006484106fa0 FDA-2019-E-3295-0002,FDA,FDA-2019-E-3295,"Patent Extension Application from Servilla Whitney LLC (on behalf of Amicus Therapeutics, Inc.)",Other,Application,2019-07-09T04:00:00Z,2019,7,2019-07-09T04:00:00Z,,2019-07-09T14:39:24Z,,0,0,0900006483d6e2ca FDA-2019-E-3295-0001,FDA,FDA-2019-E-3295,Letter from U.S. Patent and Trademark Office to FDA CDER,Other,Letter(s),2019-07-09T04:00:00Z,2019,7,2019-07-09T04:00:00Z,,2019-07-09T14:32:41Z,,0,0,0900006483d6e2c9