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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

21 rows where docket_id = "FDA-1999-D-0128" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, last_modified, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 3

  • 2008 18
  • 2007 2
  • 1999 1

document_type 3

  • Supporting & Related Material 13
  • Notice 5
  • Other 3

agency_id 1

  • FDA 21
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1999-D-0128-0010 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 2 - FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development & Manufacture of Biological Products, July 11, 1995, 60FR35750 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:03Z   0 0 09000064807caf20
FDA-1999-D-0128-0019 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 11 - Guidance for Industry: Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for a Vaccine or Related Products, January, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:00Z   0 0 09000064807caf8d
FDA-1999-D-0128-0013 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 5 - Guidance for Industry: Changes to An Approved Application: Biological Products: Human Blood & Blood Components Inteded for Transfusion or for Further Manufacture, July, 2001 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:02Z   0 0 09000064807caf4f
FDA-1999-D-0128-0021 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 13 - Guidance for Industry for the Submission of Chemistry, Manufacturing & Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use, August, 1996 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:00Z   0 0 09000064807cafb1
FDA-1999-D-0128-0016 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 8 - Guidance for Industry: On the Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for an Allergenic Extract or Allergen Patch Test, April, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:01Z   0 0 09000064807caf64
FDA-1999-D-0128-0014 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 6 - CBER Refusal to File Guidance for Product License Applications (PLAs) & Establishment License Applications (ELAs), July 12, 1993 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:02Z   0 0 09000064807caf54
FDA-1999-D-0128-0018 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 10 - Guidance for Industry: For the Submission of Chemistry, Manufacturing & Controls & Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products, February, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:01Z   0 0 09000064807caf7b
FDA-1999-D-0128-0020 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 12 - Guidance for the Submission of Chemistry, Manufacturing & Controls Information & Establishment Description for Autologous Somatic Cell Therapy Products, January, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:00Z   0 0 09000064807caf9b
FDA-1999-D-0128-0009 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 1 - FDA's Policy Statement Concerning Cooperative Manufacturing Arrangement for Licensed Biologics, November 25, 1992, 57FR55544 [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:04Z   0 0 09000064807caf14
FDA-1999-D-0128-0017 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 9 - Guidance for Industry: Content & Format of Chemistry, Manufacturing & Controls Information & Establishment Description Information for a Biological In Vitro Diagnostic Product, March, 1999 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:01Z   0 0 09000064807caf6a
FDA-1999-D-0128-0011 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 3 - Guidance for Industry: Changes to An Approved Application: Biological Products, July, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:03Z   0 0 09000064807caf26
FDA-1999-D-0128-0007 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability Notice NAD-Notice of Availability of Data 2008-12-04T05:00:00Z 2008 12 2008-12-04T15:06:23Z   2008-12-23T01:30:04Z E8-28693 0 0 09000064807cc7d2
FDA-1999-D-0128-0012 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 4 - Guidance for Industry: Changes to An Approved Application for Specified Biotechnology & Specified Synthetic Biological Products, July, 1997 - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:03Z   0 0 09000064807caf2f
FDA-1999-D-0128-0015 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Reference 7 - Guidance for Industry: For the Submission of Chemistry, Manufacturing & Controls & Establishment Description Information for Human Blood & Blood Components Intended for Transfusion or for Further Manufacture & For the Completion... - [Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability] re FDA-1999-D-0128-0008 Supporting & Related Material REF-Reference (internal unless indicated) 2008-12-04T05:00:00Z 2008 12     2008-12-23T01:30:02Z   0 0 09000064807caf5c
FDA-1999-D-0128-0006 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Cooperative Manufacturing Arrangements for Licensed Biologics - Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2008-12-03T05:00:00Z 2008 12     2008-12-05T00:32:38Z   0 0 09000064804aea2b
FDA-1999-D-0128-0008 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Guidance for Industry; Cooperative Manufacturing Arrangements for Licensed Biologics Other Guidance 2008-11-01T04:00:00Z 2008 11 2008-11-01T04:00:00Z   2020-06-30T17:57:26Z   0 0 09000064807cc900
FDA-1999-D-0128-0005 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice NAL-Notice of Approval 2008-10-09T04:00:00Z 2008 10     2008-10-09T13:29:10Z E8-23907 0 0 0900006480741127
FDA-1999-D-0128-0004 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice N-Notice 2008-10-06T04:00:00Z 2008 10 2008-10-06T04:00:00Z   2008-12-03T13:57:25Z   0 0 09000064804aea50
FDA-1999-D-0128-0003 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Notice N-Notice 2007-07-23T04:00:00Z 2007 7 2007-07-20T04:00:00Z 2007-09-22T03:59:59Z 2008-12-03T13:48:25Z   0 0 09000064804aea40
FDA-1999-D-0128-0002 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Cooperative Manufacturing Arrangements for Licensed Biologics - Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2007-07-23T04:00:00Z 2007 7     2008-12-05T00:31:53Z   0 0 09000064804aea3f
FDA-1999-D-0128-0001 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics”; Availability Notice NAD-Notice of Availability of Data 1999-08-11T04:00:00Z 1999 8 1999-08-11T04:00:00Z 1999-10-05T03:59:59Z 2025-08-06T09:00:11Z   0 0 09000064804aea26

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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);
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