{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2015-N-0648\" sorted by posted_date descending", "rows": [["FDA-2015-N-0648-0071", "FDA", "FDA-2015-N-0648", "Attachment 1 Comment from U.S. Pharmacopeial Convention Dated October 26, 2015 re Comment from U.S. Pharmacopeil Convention Dated November 12, 2015", "Supporting & Related Material", "Exhibits", "2015-11-20T05:00:00Z", 2015, 11, null, null, "2015-11-20T21:13:32Z", null, 0, 0, "0900006481d60bfd"], ["FDA-2015-N-0648-0005", "FDA", "FDA-2015-N-0648", "Reference 10-2 Celltrion Files for US FDA Approval of Remsima re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-10-29T15:31:05Z", null, 0, 0, "0900006481c3f2fc"], ["FDA-2015-N-0648-0013", "FDA", "FDA-2015-N-0648", "Reference 04- Evaluation of Medical Specialty Medications  Utilization and Management Opportunities re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:24:24Z", null, 0, 0, "0900006481c3f2f4"], ["FDA-2015-N-0648-0014", "FDA", "FDA-2015-N-0648", "Reference 03- 2010 Specialty Drug Trend Report re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:24:41Z", null, 0, 0, "0900006481c3f66c"], ["FDA-2015-N-0648-0008", "FDA", "FDA-2015-N-0648", "Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:44Z", null, 0, 0, "0900006481c3f2f9"], ["FDA-2015-N-0648-0003", "FDA", "FDA-2015-N-0648", "Reference 01- Immunogenicity Assessment for Therapeutic Protein Products re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:22:53Z", null, 0, 0, "0900006481c3f66a"], ["FDA-2015-N-0648-0007", "FDA", "FDA-2015-N-0648", "Reference 10- Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Pegfilgrastim re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:37Z", null, 0, 0, "0900006481c3f2fa"], ["FDA-2015-N-0648-0002", "FDA", "FDA-2015-N-0648", "REFERENCE LIST re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:22:24Z", null, 0, 0, "0900006481c3f669"], ["FDA-2015-N-0648-0012", "FDA", "FDA-2015-N-0648", "Reference 05- Postmarketing Spontaneous Pharmacovigilance Reporting Systems, Chapter 10, in Pharmacoepidemiology, 5th ed re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:24:13Z", null, 0, 0, "0900006481c3f2f5"], ["FDA-2015-N-0648-0011", "FDA", "FDA-2015-N-0648", "Reference 06- Evaluating the Completeness and Accuracy of MedWatch Data re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:24:05Z", null, 0, 0, "0900006481c3f2f6"], ["FDA-2015-N-0648-0001", "FDA", "FDA-2015-N-0648", "Designation of Official Names and Proper Names for Certain Biological Products", "Proposed Rule", "Notice of Proposed Rulemaking (NPRM)", "2015-08-28T04:00:00Z", 2015, 8, "2015-08-28T04:00:00Z", "2015-11-13T04:59:59Z", "2015-11-23T22:00:56Z", "2015-21382", 0, 0, "0900006481c41306"], ["FDA-2015-N-0648-0010", "FDA", "FDA-2015-N-0648", "Reference 07- ASHP Guidelines on Preventing Medication Errors With Chemotherapy and Biotherapy re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:58Z", null, 0, 0, "0900006481c3f2f7"], ["FDA-2015-N-0648-0006", "FDA", "FDA-2015-N-0648", "Reference 10-1 Hospira Submits New Biologics License Application to U.S. FDA for Proposed Epoetin Alfa Biosimilar re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:29Z", null, 0, 0, "0900006481c3f2fb"], ["FDA-2015-N-0648-0015", "FDA", "FDA-2015-N-0648", "Reference 02- Influence of the HLA-DRB1 Genotype on Antibody Development to Interferon Beta in Multiple Sclerosis re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:24:55Z", null, 0, 0, "0900006481c3f66b"], ["FDA-2015-N-0648-0004", "FDA", "FDA-2015-N-0648", "Reference 11 - Preliminary Regulatory Impact Analysis re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:13Z", null, 0, 0, "0900006481c3f2fd"], ["FDA-2015-N-0648-0009", "FDA", "FDA-2015-N-0648", "Reference 08 - StandardOrderSets re Designation of Official Names and Proper Names for Certain Biological Products", "Supporting & Related Material", "Background Material", "2015-08-28T04:00:00Z", 2015, 8, null, null, "2015-09-01T16:23:51Z", null, 0, 0, "0900006481c3f2f8"]], "truncated": false, "filtered_table_rows_count": 16, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"docket_id\" = :p0 order by posted_date desc limit 101", "params": {"p0": "FDA-2015-N-0648"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2015-N-0648", "results": [{"value": "FDA", "label": "FDA", "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&agency_id=FDA", "selected": false}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2015-N-0648", "results": [{"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 15, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&document_type=Supporting+%26+Related+Material", "selected": false}, {"value": "Proposed Rule", "label": "Proposed Rule", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&document_type=Proposed+Rule", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2015-N-0648", "results": [{"value": 2015, "label": 2015, "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&posted_year=2015", "selected": false}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet=subtype"}, {"name": "posted_date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet=posted_date"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet=posted_month"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet_date=comment_start_date"}, {"name": "comment_end_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet_date=comment_end_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2015-N-0648&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 1213.6243190034293, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}