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withdrawn,object_id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-1992-S-0039-0067,FDA,FDA-1992-S-0039,Memo Re Changes to CBER Blood Tissue Facility Registration,Other,Memorandum,2018-09-06T04:00:00Z,2018,9,2018-09-06T04:00:00Z,,2018-09-06T16:55:16Z,,0,0,09000064836b3160
FDA-1992-S-0039-0066,FDA,FDA-1992-S-0039,Registering with CVM’s Electronic Submission System Guidance for Industry,Other,Guidance,2018-05-22T04:00:00Z,2018,5,2018-05-22T04:00:00Z,,2024-11-07T01:26:25Z,,1,0,09000064832b1328
FDA-1992-S-0039-0065,FDA,FDA-1992-S-0039,CBER Memo to the Division of Dockets Management,Other,Memo,2017-09-29T04:00:00Z,2017,9,2017-09-29T04:00:00Z,,2017-09-29T15:33:48Z,,0,0,0900006482b8bbd3
FDA-1992-S-0039-0064,FDA,FDA-1992-S-0039,CBER Memo to the Division of Dockets Management,Other,Memorandum,2017-08-16T04:00:00Z,2017,8,2017-08-16T04:00:00Z,,2017-09-29T15:35:40Z,,0,0,0900006482a3ef61
FDA-1992-S-0039-0063,FDA,FDA-1992-S-0039,FDA/CVM Memo to the Division of Dockets Management Using the,Supporting & Related Material,Memorandum,2017-07-10T04:00:00Z,2017,7,,,2017-07-10T20:39:39Z,,0,0,09000064828d4c21
FDA-1992-S-0039-0062,FDA,FDA-1992-S-0039,"Letter from Epic Pharma, LLC to FDA re: Information Request Product Quality Reference #206770",Other,Letter(s),2016-02-10T05:00:00Z,2016,2,2016-02-10T05:00:00Z,,2016-02-10T19:47:23Z,,0,0,0900006481e620b5
FDA-1992-S-0039-0060,FDA,FDA-1992-S-0039,"FDA/CDRH Memo to the Division of Dockets Management Submission of Device Information (DI) record to the Global Unique Device Identification Database (GUDID), in compliance with the Unique Device Identification Rule - Memorandum",Supporting & Related Material,Background Material,2013-12-02T05:00:00Z,2013,12,,,2013-12-02T21:29:02Z,,0,0,09000064814a18df
FDA-1992-S-0039-0058,FDA,FDA-1992-S-0039,FDA/CVM Memo to the Division of Dockets Management Using the eSubmitter Tool Instead of Adobe Acrobat PDF SmartForms - Memorandum,Supporting & Related Material,Memorandum,2012-11-16T05:00:00Z,2012,11,,,2012-11-16T22:41:27Z,,0,0,0900006480f43469
FDA-1992-S-0039-0057,FDA,FDA-1992-S-0039,Guidance for Industry How to Register With the CVM Electronic Submission System to Submit Information in Electronic Format Using the FDA Electronic Submissions Gateway,Other,Guidance,2011-09-30T04:00:00Z,2011,9,2011-09-30T04:00:00Z,,2023-07-21T20:44:04Z,,0,0,0900006480f43457
FDA-1992-S-0039-0055,FDA,FDA-1992-S-0039,"FDA Center for Drug Evaluation and Research, et al to the Division of Dockets Management - Memorandum",Supporting & Related Material,Memorandum,2008-07-11T04:00:00Z,2008,7,,,2012-11-16T18:00:25Z,,0,0,090000648066936b
FDA-1992-S-0039-0056,FDA,FDA-1992-S-0039,FDA Center for Biologics Evaluation and Research to the Division of Dockets Management - Memorandum,Supporting & Related Material,Reference (internal unless indicated),2008-07-11T04:00:00Z,2008,7,,,2012-11-16T18:21:51Z,,0,0,09000064806693c4
FDA-1992-S-0039-0054,FDA,FDA-1992-S-0039,FDA Center fo Devices and Radiological Health to the Division of Dockets Management - Memorandum,Supporting & Related Material,Memorandum,2008-05-20T04:00:00Z,2008,5,,,2012-11-16T18:16:20Z,,0,0,0900006480552d61
FDA-1992-S-0039-0051,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration - Memo 26,Other,M-Memorandum,2008-05-20T04:00:00Z,2008,5,2008-05-20T04:00:00Z,,2008-05-20T14:53:47Z,,0,0,090000648052891c
FDA-1992-S-0039-0053,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration Memo 26 - Memorandum,Supporting & Related Material,Memorandum,2008-05-20T04:00:00Z,2008,5,,,2012-11-16T18:21:14Z,,0,0,0900006480528920
FDA-1992-S-0039-0052,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration - Memo 26,Other,M-Memorandum,2008-05-20T04:00:00Z,2008,5,2008-05-20T04:00:00Z,,2008-05-20T14:53:55Z,,0,0,090000648052891e
FDA-1992-S-0039-0020,FDA,FDA-1992-S-0039,"CDER to the Division of Dockets Management, Withdrawal of Case Report Forms, Memo 2 and Case Report Tabulations Memo 3 - Memorandum",Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T19:33:37Z,,0,0,090000648052889b
FDA-1992-S-0039-0022,FDA,FDA-1992-S-0039,"CBER, Biologics License Applications (BLA)Product License Applications (PLA) Establishment License Applications (ELA) New Drug Applications - Memo 8 - Supplement",Supporting & Related Material,Supplement,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T22:56:14Z,,0,0,09000064805288a0
FDA-1992-S-0039-0041,FDA,FDA-1992-S-0039,CBER Advertisements and Promotional Labeling - Memo 20,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:13Z,,0,0,09000064805288d4
FDA-1992-S-0039-0023,FDA,FDA-1992-S-0039,"CBER, CFR 601.2, 314.50 Biologics Marketing Applications - Memo 9",Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:00:40Z,,0,0,09000064805288a4
FDA-1992-S-0039-0043,FDA,FDA-1992-S-0039,CBER Investigational NDA - Memo 21,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:15Z,,0,0,09000064805288dc
FDA-1992-S-0039-0038,FDA,FDA-1992-S-0039,CDER Advertisements and Promotional Labeling Memo 18 - Memorandum,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T18:10:20Z,,0,0,09000064805288c8
FDA-1992-S-0039-0050,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration - Memo 25,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:22Z,,0,0,090000648052890d
FDA-1992-S-0039-0040,FDA,FDA-1992-S-0039,CBER Advertisements and Promotional Labeling - Memo 20,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:12Z,,0,0,09000064805288d1
FDA-1992-S-0039-0044,FDA,FDA-1992-S-0039,CBER Postmarketing Expedited and Periodic Individual Case Safety - Memo 22,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:16Z,,0,0,09000064805288df
FDA-1992-S-0039-0039,FDA,FDA-1992-S-0039,CFSAN to the Division of Dockets Management Food and Color Additive Petitions - Memo 19,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T22:44:38Z,,0,0,09000064805288cd
FDA-1992-S-0039-0032,FDA,FDA-1992-S-0039,CDER Electronic Submission of Postmarketing Expedited and Periodic Individual Case Safety Reports (ICSR) Memo 15 - Memorandum,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T20:55:12Z,,0,0,09000064805288c0
FDA-1992-S-0039-0049,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration - Memo 25,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:20Z,,0,0,090000648052890b
FDA-1992-S-0039-0035,FDA,FDA-1992-S-0039,CDER Advertisements and Promotional Labeling Memo 17 -Memorandum,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T18:04:52Z,,0,0,09000064805288c3
FDA-1992-S-0039-0048,FDA,FDA-1992-S-0039,CBER Blood Establishment Registration - Memo 25,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:19Z,,0,0,0900006480528908
FDA-1992-S-0039-0021,FDA,FDA-1992-S-0039,"CBER, Biologics License Applications (BLA)Product License Applications (PLA) Establishment License Applications (ELA) New Drug Applications - Memo 8 - Memorandum",Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T22:52:09Z,,0,0,090000648052889d
FDA-1992-S-0039-0045,FDA,FDA-1992-S-0039,CDER to the Division of Dockets Management Postmarketing Expedited and Periodic Individual Case Safety Reports Memo 23 - Memorandum,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T20:36:42Z,,0,0,09000064805288e3
FDA-1992-S-0039-0042,FDA,FDA-1992-S-0039,CBER Investigational NDA - Memo 21,Other,M-Memorandum,2008-05-19T04:00:00Z,2008,5,2008-05-19T04:00:00Z,,2008-05-19T17:53:14Z,,0,0,09000064805288d8
FDA-1992-S-0039-0037,FDA,FDA-1992-S-0039,CDER Advertisements and Promotional Labeling Memo 17 - Memorandum,Supporting & Related Material,Reference (internal unless indicated),2008-05-19T04:00:00Z,2008,5,,,2012-11-16T18:08:25Z,,0,0,09000064805288c6
FDA-1992-S-0039-0036,FDA,FDA-1992-S-0039,CDER Advertisements and Promotional Labeling Memo 17,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T18:06:50Z,,0,0,09000064805288c4
FDA-1992-S-0039-0033,FDA,FDA-1992-S-0039,FDA CDER to the Division of Docket Management Postmarketing Expedited Safety Reports 15-Day Alert Reports Memo 16 - Memorandum,Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T21:57:03Z,,0,0,09000064805288c1
FDA-1992-S-0039-0034,FDA,FDA-1992-S-0039,"FDA/CDER Postmarketing Expedited Safety Reports – 15-Day Alert Reports, Memo 16 - Memorandum",Supporting & Related Material,Memorandum,2008-05-19T04:00:00Z,2008,5,,,2012-11-16T19:47:53Z,,0,0,09000064805288c2
FDA-1992-S-0039-0027,FDA,FDA-1992-S-0039,"CVM, CFR 11.2(b)(2) Final Disposition of Memo 11 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:40:06Z,,0,1,09000064805288b7
FDA-1992-S-0039-0019,FDA,FDA-1992-S-0039,"CDER, CFR 314(50) New Drug Applications Memo 6 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T19:13:43Z,,0,1,0900006480528898
FDA-1992-S-0039-0028,FDA,FDA-1992-S-0039,CDER to the Division of Docket Postmarketing Expedited Safety Reports – “15-day Alert Reports Memo 12 - Memorandum,Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T22:45:31Z,,0,1,09000064805288bb
FDA-1992-S-0039-0025,FDA,FDA-1992-S-0039,"CVM, CFR 11.2(b)(2) Final Disposition of Memo 10",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:41:02Z,,0,1,09000064805288ac
FDA-1992-S-0039-0046,FDA,FDA-1992-S-0039,CDER Abbreviated New Drug Applications Memo 24 - Memorandum re FDA-1992-S-0039-0047,Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T20:32:56Z,,0,1,09000064805288e7
FDA-1992-S-0039-0016,FDA,FDA-1992-S-0039,"CDER, CFR 314(50)(f)(1) Case Report Tabulations Memo 3 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T19:44:54Z,,0,1,090000648052888c
FDA-1992-S-0039-0017,FDA,FDA-1992-S-0039,"CVM, CFR 511.1, NCIE, Notices of Claimed Memo 4 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T16:51:56Z,,0,1,0900006480528890
FDA-1992-S-0039-0014,FDA,FDA-1992-S-0039,"CVM, CFR 511.1, NCIE, Notices of Claimed Memo - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T16:52:19Z,,0,1,0900006480528878
FDA-1992-S-0039-0026,FDA,FDA-1992-S-0039,"CVM, CFR 11.2(b)(2) Final Disposition of Memo 11 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:40:38Z,,0,1,09000064805288b4
FDA-1992-S-0039-0030,FDA,FDA-1992-S-0039,"CVM, Guidance for Industry #59: Submit Memo 14 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:48:09Z,,0,1,09000064805288be
FDA-1992-S-0039-0029,FDA,FDA-1992-S-0039,CVM CFR 11.2(b) (2) Guidance for Indudstry Memo 13 - Memorandum,Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:44:17Z,,0,1,09000064805288bd
FDA-1992-S-0039-0024,FDA,FDA-1992-S-0039,"CVM, CFR 11.2(b)(2) Final Disposition of Memo 10 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:41:35Z,,0,1,09000064805288a8
FDA-1992-S-0039-0018,FDA,FDA-1992-S-0039,"CVM, CFR 511.1, NCIE, Notices of Claimed Memo 5 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T16:53:26Z,,0,1,0900006480528894
FDA-1992-S-0039-0015,FDA,FDA-1992-S-0039,"CDER, CFR 314 (50)(f)(2) Case Report Forms Memo 2 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T19:41:05Z,,0,1,0900006480528889
FDA-1992-S-0039-0047,FDA,FDA-1992-S-0039,CDER Abbreviated New Drug Applications Memo 24 - Memorandum,Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T20:30:53Z,,0,1,0900006480528906
FDA-1992-S-0039-0031,FDA,FDA-1992-S-0039,"CVM, Guidance for Industry #59: Submit Memo 14 - Memorandum",Supporting & Related Material,,2008-05-19T00:00:00Z,2008,5,,,2012-11-16T17:50:31Z,,0,1,09000064805288bf
FDA-1992-S-0039-0013,FDA,FDA-1992-S-0039,"CDER to the Division of Dockets Management Investigational New Drug Applications, New Drug Applications, Biologics Licensing Applications, Abbreviated New Drug Applications, Master Files, and Annual Reports, Memo 34 - Memorandum",Supporting & Related Material,Memorandum,2007-09-13T04:00:00Z,2007,9,,,2012-11-16T22:46:28Z,,0,0,090000648052892d
FDA-1992-S-0039-0012,FDA,FDA-1992-S-0039,Food and Drug Administration Electronic Submissions Gateway (ESG),Notice,Notice of Availability,2006-08-08T04:00:00Z,2006,8,2006-08-07T04:00:00Z,,2011-09-23T15:36:20Z,,0,0,090000648052892c
FDA-1992-S-0039-0010,FDA,FDA-1992-S-0039,CDER to the Division of Dockets Management Orphan-Drug Designation Requests Memo 33 - Memorandum,Supporting & Related Material,Memorandum,2006-04-18T04:00:00Z,2006,4,,,2012-11-16T21:01:49Z,,0,0,090000648052892a
FDA-1992-S-0039-0011,FDA,FDA-1992-S-0039,CDER to the Division of Dockets Management Orphan-Drug Designation Requests Memo 33 - Memorandum,Supporting & Related Material,Memorandum,2006-04-18T04:00:00Z,2006,4,,,2012-11-16T21:04:55Z,,0,0,090000648052892b
FDA-1992-S-0039-0009,FDA,FDA-1992-S-0039,CDER Content of Labeling in Electronic Format Using the Health Level Seven (HL7) Stntctured Product Labeling (SPL) Standard Memo 32 - Memorandum re Updates Memorandum 31,Supporting & Related Material,Memorandum,2005-10-25T04:00:00Z,2005,10,,,2012-11-16T22:18:24Z,,0,0,0900006480528929
FDA-1992-S-0039-0008,FDA,FDA-1992-S-0039,CDER Content of Labeling in Electronic Format Using the Health Level Seven (HL7) Stntctured Product Labeling (SPL) Standard Memo 31 - Memorandum,Supporting & Related Material,Memorandum,2004-09-27T04:00:00Z,2004,9,,,2012-11-16T22:13:31Z,,0,0,0900006480528928
FDA-1992-S-0039-0007,FDA,FDA-1992-S-0039,CDER New Drug Application/Abbreviated New Drug Application Annual Reports Memo 30 - Memorandum,Supporting & Related Material,,2004-04-07T00:00:00Z,2004,4,,,2012-11-16T19:25:18Z,,0,1,0900006480528927
FDA-1992-S-0039-0005,FDA,FDA-1992-S-0039,ORA to the Division of Dockets Management New Drug Applications and Abbreviated New Drug Applications Field Copy Memo 29 - Memorandum re FDA-1992-S-0039-0006,Supporting & Related Material,Background Material,2003-09-30T04:00:00Z,2003,9,,,2012-11-16T22:08:41Z,,0,0,0900006480528925
FDA-1992-S-0039-0006,FDA,FDA-1992-S-0039,ORA to the Division of Dockets Management New Drug Applications and Abbreviated New Drug Applications Field Copy Memo 29 - Memorandum,Supporting & Related Material,Memorandum,2003-09-30T04:00:00Z,2003,9,,,2012-11-16T22:07:21Z,,0,0,0900006480528926
FDA-1992-S-0039-0004,FDA,FDA-1992-S-0039,CDER Postmarketing Expedited and Periodic Individual Case Safety Reports including Descriptive Material Memo 28 - Memorandum,Supporting & Related Material,Memorandum,2003-09-24T04:00:00Z,2003,9,,,2012-11-16T21:12:12Z,,0,0,0900006480528924
FDA-1992-S-0039-0003,FDA,FDA-1992-S-0039,CDER Investigational New Drug Applications  New Drug Applications Abbreviated NewDrug Applications Master Files Annual Reports Promotional Material Memo 27 - Memorandum,Supporting & Related Material,Memorandum,2003-08-27T04:00:00Z,2003,8,,,2012-11-16T21:55:28Z,,0,0,0900006480528922
FDA-1992-S-0039-0002,FDA,FDA-1992-S-0039,CDER Investigational New Drug Applications  New Drug Applications Abbreviated NewDrug Applications Master Files Annual Reports Promotional Material Memo 27 - Memorandum,Supporting & Related Material,Memorandum,2003-08-27T04:00:00Z,2003,8,,,2012-11-16T21:41:36Z,,0,0,0900006480528921
FDA-1992-S-0039-0001,FDA,FDA-1992-S-0039,Electronic Submissions; Establishment of Public Docket,Notice,N-Notice,1997-03-20T05:00:00Z,1997,3,,,2012-11-16T16:36:27Z,Vol 62 No 54,0,0,090000648052882e