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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

16 rows where docket_id = "FDA-2015-N-0648" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 15
  • Proposed Rule 1

posted_year 1

  • 2015 16

agency_id 1

  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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FDA-2015-N-0648-0008 FDA None FDA-2015-N-0648 Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products Supporting & Related Material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;
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