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withdrawn,object_id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-1149-0108,FDA,FDA-2016-N-1149,FDA Summary of Premarket Review and Related Authorities for Medical Products _Jan 2025,Other,Summary (SUM),2025-01-06T05:00:00Z,2025,1,2025-01-06T05:00:00Z,,2025-01-06T13:37:41Z,,0,0,090000648689e39a
FDA-2016-N-1149-0107,FDA,FDA-2016-N-1149,Addendum to Jan 2017 FDA Memo--Additional and Updated Considerations Related to Manufacturer Communications Re Unapproved Uses of Approved or Cleared Medical Products_Jan 2025,Other,Additional Information,2025-01-06T05:00:00Z,2025,1,2025-01-06T05:00:00Z,,2025-01-06T13:37:28Z,,0,0,090000648689e398
FDA-2016-N-1149-0106,FDA,FDA-2016-N-1149,Letter from Ropes & Gray on behalf of Medical Information Working Group (MIWG) to FDA,Other,Letter(s),2019-12-03T05:00:00Z,2019,12,2019-12-03T05:00:00Z,,2019-12-03T14:16:13Z,,0,0,09000064841dde4b
FDA-2016-N-1149-0105,FDA,FDA-2016-N-1149,Kalb et al_IU Final Rule_Response_3-26-18,Other,Agency Response,2018-04-09T04:00:00Z,2018,4,2018-04-09T04:00:00Z,,2018-04-09T21:13:27Z,,0,0,09000064830e95e5
FDA-2016-N-1149-0104,FDA,FDA-2016-N-1149,Petition Interim Response from FDA OP to MIWG,Other,Letter(s),2017-08-01T04:00:00Z,2017,8,2017-08-01T04:00:00Z,,2017-08-01T14:42:16Z,,0,0,0900006482990a65
FDA-2016-N-1149-0087,FDA,FDA-2016-N-1149,Testimony from Anthem Inc.,Other,Testimony,2017-04-20T04:00:00Z,2017,4,2017-04-20T04:00:00Z,,2017-04-20T18:59:26Z,,0,0,0900006482560beb
FDA-2016-N-1149-0093,FDA,FDA-2016-N-1149,Testimony from Pfizer Inc.,Other,Testimony,2017-04-20T04:00:00Z,2017,4,2017-04-20T04:00:00Z,,2017-04-20T19:06:43Z,,0,0,0900006482561a8d
FDA-2016-N-1149-0075,FDA,FDA-2016-N-1149,Testimony from PharmedOut,Other,Testimony,2017-04-20T04:00:00Z,2017,4,2017-04-20T04:00:00Z,,2017-04-20T16:36:19Z,,0,0,090000648255df72
FDA-2016-N-1149-0048,FDA,FDA-2016-N-1149,Petition to Stay and for Reconsideration,Other,Petition(s),2017-02-09T05:00:00Z,2017,2,2017-02-09T05:00:00Z,,2017-02-09T15:17:05Z,,0,0,09000064824b6785
FDA-2016-N-1149-0049,FDA,FDA-2016-N-1149,Acknowledgement Letter From FDA DDM to Sidley Austin LLP and Ropes & Gray LLP,Other,Acknowledgement Letter/Receipt,2017-02-09T05:00:00Z,2017,2,2017-02-09T05:00:00Z,,2017-02-09T16:47:18Z,,0,0,09000064824b6e17
FDA-2016-N-1149-0041,FDA,FDA-2016-N-1149,Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period,Proposed Rule,Reopening of Comment Period,2017-01-19T05:00:00Z,2017,1,2017-01-19T05:00:00Z,2017-04-20T03:59:59Z,2017-06-23T01:03:12Z,2017-01013,0,0,090000648248561c
FDA-2016-N-1149-0040,FDA,FDA-2016-N-1149,FDA Memorandum--Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products_Jan 2017,Other,Letter(s),2017-01-18T05:00:00Z,2017,1,2017-01-18T05:00:00Z,,2017-01-18T15:22:04Z,,0,0,0900006482480cf8
FDA-2016-N-1149-0018,FDA,FDA-2016-N-1149,Testimony from American Association of Neurological Surgeons and Congress of Neurological Surgeons,Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T21:10:43Z,,0,0,09000064823ba7a1
FDA-2016-N-1149-0013,FDA,FDA-2016-N-1149,Testimony from Advanced Medical Technology Association (AdvaMed),Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T20:15:59Z,,0,0,0900006482381f85
FDA-2016-N-1149-0012,FDA,FDA-2016-N-1149,Testimony from Biotechnology Innovation Organization (BIO),Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T20:14:51Z,,0,0,090000648238157d
FDA-2016-N-1149-0022,FDA,FDA-2016-N-1149,Testimony from Jerome Lew,Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T21:30:38Z,,0,0,09000064823f9294
FDA-2016-N-1149-0014,FDA,FDA-2016-N-1149,Testimony from National Women's Health Network,Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T20:23:47Z,,0,0,0900006482397fc5
FDA-2016-N-1149-0011,FDA,FDA-2016-N-1149,Testimony from Floyd Abrams,Other,Testimony,2016-12-14T05:00:00Z,2016,12,2016-12-14T05:00:00Z,,2016-12-14T19:38:38Z,,0,0,0900006482364d05
FDA-2016-N-1149-0008,FDA,FDA-2016-N-1149,"Transcript of Day 1 on November 9, 2016",Other,Transcript(s),2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T17:12:36Z,,0,0,09000064824016af
FDA-2016-N-1149-0009,FDA,FDA-2016-N-1149,"Transcript of Day 2 on November 10, 2016",Other,Transcript(s),2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T17:13:48Z,,0,0,09000064824016b0
FDA-2016-N-1149-0006,FDA,FDA-2016-N-1149,Testimony from MMpiHer Consulting,Other,Testimony,2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,,2016-10-26T16:02:52Z,,0,0,090000648234f639
FDA-2016-N-1149-0001,FDA,FDA-2016-N-1149,Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments,Proposed Rule,Notice of Hearing,2016-09-01T04:00:00Z,2016,9,2016-09-01T04:00:00Z,2017-04-20T03:59:59Z,2017-04-21T01:02:02Z,2016-21062,0,0,09000064821bd14a