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withdrawn,object_id FDA-2008-N-0424-0039,FDA,FDA-2008-N-0424,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-11-12T05:00:00Z,2020,11,2020-11-12T05:00:00Z,,2020-11-12T15:06:25Z,2020-25019,0,0,090000648495a208 FDA-2008-N-0424-0038,FDA,FDA-2008-N-0424,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products,Notice,30 Day Proposed Information Collection,2020-08-05T04:00:00Z,2020,8,2020-08-05T04:00:00Z,2020-09-05T03:59:59Z,2020-08-05T13:47:16Z,2020-17041,0,0,09000064847d721d FDA-2008-N-0424-0037,FDA,FDA-2008-N-0424,Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products,Notice,60 Day Proposed Information Collection,2020-04-30T04:00:00Z,2020,4,2020-04-30T04:00:00Z,2020-06-30T03:59:59Z,2020-05-01T19:26:19Z,2020-09175,0,0,09000064845283a6 FDA-2008-N-0424-0035,FDA,FDA-2008-N-0424,Final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products; Availability,Notice,Notice of Availability,2019-07-23T04:00:00Z,2019,7,2019-07-23T04:00:00Z,,2019-07-23T17:09:15Z,2019-15595,0,0,0900006483da9f72 FDA-2008-N-0424-0036,FDA,FDA-2008-N-0424,Guidance for Industry on Postmarketing Safety Reporting for Combination Products,Other,Guidance,2019-07-22T04:00:00Z,2019,7,2019-07-22T04:00:00Z,,2024-11-12T23:05:01Z,,1,0,0900006483dab261 FDA-2008-N-0424-0034,FDA,FDA-2008-N-0424,Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability,Rule,Correction,2019-04-24T04:00:00Z,2019,4,2019-04-24T04:00:00Z,,2019-07-23T11:14:49Z,2019-08284,0,0,0900006483be9a6e FDA-2008-N-0424-0024,FDA,FDA-2008-N-0424,"Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability",Notice,Notice of Availability,2018-03-21T04:00:00Z,2018,3,2018-03-21T04:00:00Z,,2019-07-23T11:13:53Z,2018-05688,0,0,0900006483035dd7 FDA-2008-N-0424-0025,FDA,FDA-2008-N-0424,Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2018-03-21T04:00:00Z,2018,3,2018-03-21T04:00:00Z,,2024-11-07T01:24:51Z,,1,0,09000064830371ce FDA-2008-N-0424-0023,FDA,FDA-2008-N-0424,Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff DRAFT GUIDANCE,Other,Guidance,2018-03-21T04:00:00Z,2018,3,2018-03-21T04:00:00Z,2018-06-20T03:59:59Z,2019-10-23T14:45:31Z,,0,0,090000648302e3eb FDA-2008-N-0424-0022,FDA,FDA-2008-N-0424,Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Proposed Rule,GDL Guidance,2018-03-21T04:00:00Z,2018,3,2018-03-21T04:00:00Z,2018-06-20T03:59:59Z,2018-03-21T13:13:54Z,2018-05687,0,0,09000064830356f0 FDA-2008-N-0424-0019,FDA,FDA-2008-N-0424,Postmarketing Safety Reporting for Combination Products,Rule,Final Rule,2016-12-20T05:00:00Z,2016,12,2016-12-20T05:00:00Z,,2016-12-20T15:03:50Z,2016-30485,0,0,0900006482429777 FDA-2008-N-0424-0020,FDA,FDA-2008-N-0424,DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC HEARING ON: FDA REGULATION OF COMBINATION PRODUCTS,Supporting & Related Material,Background Material,2016-12-20T05:00:00Z,2016,12,,,2016-12-20T16:15:31Z,,0,0,090000648242a391 FDA-2008-N-0424-0021,FDA,FDA-2008-N-0424,Regulatory Impact Assessment for Postmarketing Safety Reporting for Combination Products,Supporting & Related Material,Background Material,2016-12-20T05:00:00Z,2016,12,,,2016-12-20T17:11:22Z,,0,0,090000648242a394 FDA-2008-N-0424-0004,FDA,FDA-2008-N-0424,Postmarketing Safety Reporting for Combination Products; Extension of Comment Period,Notice,NPR-Notice of Proposed Rule-Making,2009-12-11T05:00:00Z,2009,12,2009-12-11T05:00:00Z,2010-01-30T04:59:59Z,2011-06-11T16:27:47Z,E9-29493,0,0,0900006480a692a4 FDA-2008-N-0424-0001,FDA,FDA-2008-N-0424,Postmarketing Safety Reporting for Combination Products,Proposed Rule,NPR-Notice of Proposed Rule-Making,2009-10-01T04:00:00Z,2009,10,2009-10-01T04:00:00Z,2009-12-31T04:59:59Z,2011-06-11T16:27:47Z,E9-23519,0,0,0900006480a34de0