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withdrawn,object_id FDA-2016-D-4308-0008,FDA,FDA-2016-D-4308,Reference 5 Blood Product Advisory ommittee Meeting Transcripts_ Dec 4 2012 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:53Z,,0,0,0900006482446f1b FDA-2016-D-4308-0011,FDA,FDA-2016-D-4308,09 Reference 8 FDA Guidance for Industry Computer Crossmatch Computerized Analysis of the Compatibility between the Donors Cell Type and the Recipients Serum or Plasma Type April 2011 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:14:06Z,,0,0,0900006482446f1e FDA-2016-D-4308-0004,FDA,FDA-2016-D-4308,Reference 1 Daniels G Reid ME Blood groups the past 50 years Transfusion 2010 Feb 50_2_281_9 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:38Z,,0,0,0900006482446e45 FDA-2016-D-4308-0012,FDA,FDA-2016-D-4308,10 Reference 9 FDA Guidance for Industry For the Submission of Chemistry Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:14:09Z,,0,0,0900006482446f1f FDA-2016-D-4308-0005,FDA,FDA-2016-D-4308,Reference 2 Poole J Daniels G Blood group antibodies and their significance in transfusion medicine Transfus Med Rev 2007 21_58_71 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:41Z,,0,0,0900006482446f18 FDA-2016-D-4308-0001,FDA,FDA-2016-D-4308,"Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2017-01-03T05:00:00Z,2017,1,2017-01-03T05:00:00Z,,2017-01-03T14:44:35Z,2016-31771,0,0,0900006482445ef6 FDA-2016-D-4308-0003,FDA,FDA-2016-D-4308,RBC Antigen Reference List re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:34Z,,0,0,0900006482446e44 FDA-2016-D-4308-0006,FDA,FDA-2016-D-4308,Reference 3 Compliance Program Guidance Manual Chapter 42 Blood and Blood Components Inspection of Licensed and Unlicensed Blood Banks Brokers Reference Laboratories and Contractors 7342_001 dated Jun 1 16 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:44Z,,0,0,0900006482446f19 FDA-2016-D-4308-0010,FDA,FDA-2016-D-4308,Reference 7 FDA Guidance for Industry Biological Product Deviation Reporting for Blood and Plasma Establishments October 2006 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:14:03Z,,0,0,0900006482446f1d FDA-2016-D-4308-0009,FDA,FDA-2016-D-4308,Reference 6 AABB Standards for Blood Banks and Transfusion Services 30th edition re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:59Z,,0,0,0900006482446f1c FDA-2016-D-4308-0002,FDA,FDA-2016-D-4308,"Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry",Other,Guidance,2017-01-03T05:00:00Z,2017,1,2017-01-03T05:00:00Z,2017-04-04T03:59:59Z,2024-11-07T23:52:00Z,,1,0,0900006482446e42 FDA-2016-D-4308-0007,FDA,FDA-2016-D-4308,Reference 4 AABB_FDA Liaison Meeting April 12 2012 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:13:50Z,,0,0,0900006482446f1a FDA-2016-D-4308-0013,FDA,FDA-2016-D-4308,Reference 10 FDA Guidance for Industry Availability of FDAs e_Submitter Program for Regulatory Submissions from Licensed Blood Establishments August 2011 re Labeling of Red Blood Cell Units with Historical Antigen Typing Results Draft Guidance for Industry,Supporting & Related Material,Background Material,2017-01-03T05:00:00Z,2017,1,,,2017-01-03T15:14:12Z,,0,0,0900006482446f20