documents
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)
document_type 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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);