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withdrawn,object_id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-1995-D-0288-0051,FDA,FDA-1995-D-0288,"Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:19Z,,0,0,0900006484bd4b2d
FDA-1995-D-0288-0053,FDA,FDA-1995-D-0288,"Ref. 9 - Comparability Protocols for Human Drugs and Biologics April 2016 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:31Z,,0,0,0900006484bd4b2f
FDA-1995-D-0288-0054,FDA,FDA-1995-D-0288,"Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:37Z,,0,0,0900006484bd4b30
FDA-1995-D-0288-0052,FDA,FDA-1995-D-0288,"Ref. 7 - ICH Q 12 Annex RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:25Z,,0,0,0900006484bd4b2e
FDA-1995-D-0288-0055,FDA,FDA-1995-D-0288,"Ref. 23 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research March 2019 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:44Z,,0,0,0900006484bd4b31
FDA-1995-D-0288-0050,FDA,FDA-1995-D-0288,"PAC FINAL GUIDANCE reference list RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:11Z,,0,0,0900006484bcd0c7
FDA-1995-D-0288-0049,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Other,Guidance,2021-06-24T04:00:00Z,2021,6,2021-06-24T04:00:00Z,,2024-11-12T23:32:40Z,,1,0,0900006484baa9ff
FDA-1995-D-0288-0048,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability",Notice,Notice of Availability,2021-06-24T04:00:00Z,2021,6,2021-06-24T04:00:00Z,,2021-06-24T14:02:39Z,2021-13392,0,0,0900006484ba948e