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withdrawn,object_id FDA-2018-D-0481-0011,FDA,FDA-2018-D-0481,Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-09T05:00:00Z,2024,12,,,2024-12-09T14:34:19Z,2024-28807,0,0,0900006486856197 FDA-2018-D-0481-0012,FDA,FDA-2018-D-0481,Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry,Other,Guidance,2024-12-09T05:00:00Z,2024,12,2024-12-09T05:00:00Z,,2024-12-09T14:32:35Z,,1,0,090000648685643b FDA-2018-D-0481-0003,FDA,FDA-2018-D-0481,Technical Specifications-Standardized Format for Electronic Submission of NDA BLA Content for BIMO,Other,Background Material,2018-02-21T05:00:00Z,2018,2,2018-02-21T05:00:00Z,,2018-02-21T14:39:26Z,,0,0,0900006482f4d097 FDA-2018-D-0481-0002,FDA,FDA-2018-D-0481,Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry; Draft Guidance,Other,Guidance,2018-02-21T05:00:00Z,2018,2,2018-02-21T05:00:00Z,2018-04-18T03:59:59Z,2024-12-09T14:32:52Z,,0,0,0900006482f4d04b FDA-2018-D-0481-0001,FDA,FDA-2018-D-0481,"Submission of Content Necessary for Bioresearch Monitoring Inspection Planning for the Center of Drug Evaluation and Research; Availability",Notice,Notice of Availability,2018-02-16T05:00:00Z,2018,2,2018-02-16T05:00:00Z,2018-04-18T03:59:59Z,2018-04-14T01:02:35Z,2018-03236,0,0,0900006482f3897d