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withdrawn,object_id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-2019-N-1363-0033,FDA,FDA-2019-N-1363,Reference 3 Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and Food and Drug Administration Staff,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:20:36Z,,0,0,0900006486400aee
FDA-2019-N-1363-0031,FDA,FDA-2019-N-1363,Reference 1 Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:18:21Z,,0,0,0900006486400aec
FDA-2019-N-1363-0032,FDA,FDA-2019-N-1363,Referece 2 Cooperative-Manufacturing Arrangements for Licensed Biologics,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:19:22Z,,0,0,0900006486400aed
FDA-2019-N-1363-0035,FDA,FDA-2019-N-1363,Reference 5 Drug Master Files Guidance for Industry,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:22:39Z,,0,0,0900006486400af0
FDA-2019-N-1363-0036,FDA,FDA-2019-N-1363,Reference 6 Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:24:06Z,,0,0,0900006486400af1
FDA-2019-N-1363-0029,FDA,FDA-2019-N-1363,Biologics License Applications and Master Files,Rule,Final Rule,2024-02-12T05:00:00Z,2024,2,2024-02-12T05:00:00Z,,2024-02-12T14:12:23Z,2024-02741,0,0,09000064864008a6
FDA-2019-N-1363-0030,FDA,FDA-2019-N-1363,List of References,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:16:49Z,,0,0,0900006486400aeb
FDA-2019-N-1363-0034,FDA,FDA-2019-N-1363,Reference 4 Biosimilars Action Plan,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:21:40Z,,0,0,0900006486400aef
FDA-2019-N-1363-0037,FDA,FDA-2019-N-1363,Reference 7 BLAs and Master Files Final Reg Impact Analysis,Supporting & Related Material,Background Material,2024-02-12T05:00:00Z,2024,2,,,2024-02-12T14:25:02Z,,0,0,0900006486400af3
FDA-2019-N-1363-0001,FDA,FDA-2019-N-1363,Biologics License Applications and Master Files,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2019-06-28T04:00:00Z,2019,6,2019-06-28T04:00:00Z,2019-08-28T03:59:59Z,2019-08-28T01:03:12Z,2019-13753,0,0,0900006483d4af9c