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16 rows where docket_id = "FDA-2015-N-0648" sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2015-N-0648-0071 | FDA | None 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 | 2015-11-20T21:13:32Z | 0 | 0 | 0900006481d60bfd | |||
| FDA-2015-N-0648-0005 | FDA | None 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 | 2015-10-29T15:31:05Z | 0 | 0 | 0900006481c3f2fc | |||
| FDA-2015-N-0648-0013 | FDA | None 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 | 2015-09-01T16:24:24Z | 0 | 0 | 0900006481c3f2f4 | |||
| FDA-2015-N-0648-0014 | FDA | None 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 | 2015-09-01T16:24:41Z | 0 | 0 | 0900006481c3f66c | |||
| FDA-2015-N-0648-0008 | FDA | None FDA-2015-N-0648 | Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products | Supporting & Related Material |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 | 2015-09-01T16:23:44Z | 0 | 0 | 0900006481c3f2f9 | |||
| FDA-2015-N-0648-0003 | FDA | None 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 | 2015-09-01T16:22:53Z | 0 | 0 | 0900006481c3f66a | |||
| FDA-2015-N-0648-0007 | FDA | None 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 | 2015-09-01T16:23:37Z | 0 | 0 | 0900006481c3f2fa | |||
| FDA-2015-N-0648-0002 | FDA | None 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 | 2015-09-01T16:22:24Z | 0 | 0 | 0900006481c3f669 | |||
| FDA-2015-N-0648-0012 | FDA | None 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 | 2015-09-01T16:24:13Z | 0 | 0 | 0900006481c3f2f5 | |||
| FDA-2015-N-0648-0011 | FDA | None 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 | 2015-09-01T16:24:05Z | 0 | 0 | 0900006481c3f2f6 | |||
| FDA-2015-N-0648-0001 | FDA | None 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 | None 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 | 2015-09-01T16:23:58Z | 0 | 0 | 0900006481c3f2f7 | |||
| FDA-2015-N-0648-0006 | FDA | None 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 | 2015-09-01T16:23:29Z | 0 | 0 | 0900006481c3f2fb | |||
| FDA-2015-N-0648-0015 | FDA | None 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 | 2015-09-01T16:24:55Z | 0 | 0 | 0900006481c3f66b | |||
| FDA-2015-N-0648-0004 | FDA | None 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 | 2015-09-01T16:23:13Z | 0 | 0 | 0900006481c3f2fd | |||
| FDA-2015-N-0648-0009 | FDA | None 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 | 2015-09-01T16:23:51Z | 0 | 0 | 0900006481c3f2f8 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;