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withdrawn,object_id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-1999-D-0128-0010,FDA,FDA-1999-D-0128,"Reference 2 - FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development & Manufacture of Biological Products, July 11, 1995, 60FR35750 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:03Z,,0,0,09000064807caf20
FDA-1999-D-0128-0019,FDA,FDA-1999-D-0128,"Reference 11 - Guidance for Industry: Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for a Vaccine or Related Products, January, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:00Z,,0,0,09000064807caf8d
FDA-1999-D-0128-0013,FDA,FDA-1999-D-0128,"Reference 5 - Guidance for Industry: Changes to An Approved Application: Biological Products: Human Blood & Blood Components Inteded for Transfusion or for Further Manufacture, July, 2001 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:02Z,,0,0,09000064807caf4f
FDA-1999-D-0128-0021,FDA,FDA-1999-D-0128,"Reference 13 - Guidance for Industry for the Submission of Chemistry, Manufacturing & Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use, August, 1996 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:00Z,,0,0,09000064807cafb1
FDA-1999-D-0128-0016,FDA,FDA-1999-D-0128,"Reference 8 - Guidance for Industry: On the Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for an Allergenic Extract or Allergen Patch Test, April, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:01Z,,0,0,09000064807caf64
FDA-1999-D-0128-0014,FDA,FDA-1999-D-0128,"Reference 6 - CBER Refusal to File Guidance for Product License Applications (PLAs) & Establishment License Applications (ELAs), July 12, 1993 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:02Z,,0,0,09000064807caf54
FDA-1999-D-0128-0018,FDA,FDA-1999-D-0128,"Reference 10 - Guidance for Industry: For the Submission of Chemistry, Manufacturing & Controls & Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products, February, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:01Z,,0,0,09000064807caf7b
FDA-1999-D-0128-0020,FDA,FDA-1999-D-0128,"Reference 12 - Guidance for the Submission of Chemistry, Manufacturing & Controls Information & Establishment Description for Autologous Somatic Cell Therapy Products, January, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:00Z,,0,0,09000064807caf9b
FDA-1999-D-0128-0009,FDA,FDA-1999-D-0128,"Reference 1 - FDA's Policy Statement Concerning Cooperative Manufacturing Arrangement for Licensed Biologics, November 25, 1992, 57FR55544 [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:04Z,,0,0,09000064807caf14
FDA-1999-D-0128-0017,FDA,FDA-1999-D-0128,"Reference 9 - Guidance for Industry: Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for a Biological In Vitro Diagnostic Product, March, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:01Z,,0,0,09000064807caf6a
FDA-1999-D-0128-0011,FDA,FDA-1999-D-0128,"Reference 3 - Guidance for Industry: Changes to An Approved Application: Biological Products, July, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:03Z,,0,0,09000064807caf26
FDA-1999-D-0128-0007,FDA,FDA-1999-D-0128,Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability,Notice,NAD-Notice of Availability of Data,2008-12-04T05:00:00Z,2008,12,2008-12-04T15:06:23Z,,2008-12-23T01:30:04Z,E8-28693,0,0,09000064807cc7d2
FDA-1999-D-0128-0012,FDA,FDA-1999-D-0128,"Reference 4 - Guidance for Industry: Changes to An Approved Application for Specified Biotechnology & Specified Synthetic Biological Products, July, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:03Z,,0,0,09000064807caf2f
FDA-1999-D-0128-0015,FDA,FDA-1999-D-0128,"Reference 7 - Guidance for Industry: For the Submission of Chemistry, Manufacturing & Controls & Establishment Description Information for Human Blood & Blood Components Intended for Transfusion or for Further Manufacture & For the Completion... - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008",Supporting & Related Material,REF-Reference (internal unless indicated),2008-12-04T05:00:00Z,2008,12,,,2008-12-23T01:30:02Z,,0,0,09000064807caf5c
FDA-1999-D-0128-0006,FDA,FDA-1999-D-0128,Cooperative Manufacturing Arrangements for Licensed Biologics - Draft Guidance,Other,GDL-Guidance (Supporting and Related Materials),2008-12-03T05:00:00Z,2008,12,,,2008-12-05T00:32:38Z,,0,0,09000064804aea2b
FDA-1999-D-0128-0008,FDA,FDA-1999-D-0128,Guidance for Industry; Cooperative Manufacturing Arrangements for Licensed Biologics,Other,Guidance,2008-11-01T04:00:00Z,2008,11,2008-11-01T04:00:00Z,,2020-06-30T17:57:26Z,,0,0,09000064807cc900
FDA-1999-D-0128-0005,FDA,FDA-1999-D-0128,Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics,Notice,NAL-Notice of Approval,2008-10-09T04:00:00Z,2008,10,,,2008-10-09T13:29:10Z,E8-23907,0,0,0900006480741127
FDA-1999-D-0128-0004,FDA,FDA-1999-D-0128,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics,Notice,N-Notice,2008-10-06T04:00:00Z,2008,10,2008-10-06T04:00:00Z,,2008-12-03T13:57:25Z,,0,0,09000064804aea50