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43 rows where docket_id = "FDA-2005-N-0464" sorted by posted_date descending
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document_type 5
- Supporting & Related Material 15
- Other 14
- Proposed Rule 6
- Notice 5
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agency_id 1
- FDA 43
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2005-N-0464-0249 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections | Rule | Final Rule | 2021-04-01T04:00:00Z | 2021 | 4 | 2021-04-01T04:00:00Z | 2021-04-01T15:35:43Z | 2021-06677 | 0 | 0 | 0900006484a93032 | |
| FDA-2005-N-0464-0244 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing | Notice | Announcement | 2017-04-25T04:00:00Z | 2017 | 4 | 2017-04-25T04:00:00Z | 2017-04-25T14:08:22Z | 2017-08305 | 0 | 0 | 090000648257352e | |
| FDA-2005-N-0464-0241 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Tab 3: Draft Final Economic Impact Analysis for a Prospective FDA Rule Governing: Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs - dated on 08/03/2005 | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-08-15T14:19:34Z | 0 | 0 | 0900006480450bff | |||
| FDA-2005-N-0464-0243 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Tab 5: Cost Impacts of the Over-the-Counter Pharmaceutical Labeling Rule - final report dated on 03/05/1999 | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-08-15T14:26:29Z | 0 | 0 | 0900006480450bfe | |||
| FDA-2005-N-0464-0242 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Tab 4: Profile of the Prescription drug wholesaling Industry: Examination of Entities Defining Supply and Demand in Drug Distribution - Final Report dated on 02/12/2001 | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-08-15T14:24:05Z | 0 | 0 | 0900006480450bfa | |||
| FDA-2005-N-0464-0240 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Tab 2: Letter from FDA/CDER to Eugene S. Peiser & Associates Dated on 08/25/1997 | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-08-15T14:16:37Z | 0 | 0 | 0900006480450bf8 | |||
| FDA-2005-N-0464-0239 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Tab 1: Letter from National Association of CHAIN DRUG STORES(NACDS) to FDA/CDER on 09/27/2004 | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-08-15T14:13:32Z | 0 | 0 | 0900006480450bfc | |||
| FDA-2005-N-0464-0238 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction | Rule | Final Rule | 2016-12-13T05:00:00Z | 2016 | 12 | 2016-12-13T05:00:00Z | 2016-12-13T14:31:48Z | 2016-29774 | 0 | 0 | 09000064823fed93 | |
| FDA-2005-N-0464-0235 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that Are Regulated Under a Biologics License Application, and Animal Drugs | Supporting & Related Material | Background Material | 2016-08-31T04:00:00Z | 2016 | 8 | 2016-08-31T14:33:56Z | 0 | 0 | 09000064821b7bb5 | |||
| FDA-2005-N-0464-0237 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Ref2_ERG Revisions 1995 DRAFT FINAL REPORT ECONOMIC THRESHOLD AND REGULATORY FLEXIBILITY ASSESSMENT OF PROPOSED CHANGES TO THE CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS FOR MANUFACTURING, PROCESSING, PACKING, OR HOLDING DRUGS (21CFR210&211) re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under | Supporting & Related Material | Background Material | 2016-08-31T04:00:00Z | 2016 | 8 | 2016-08-31T14:37:59Z | 0 | 0 | 09000064821b7bb7 | |||
| FDA-2005-N-0464-0236 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Ref1_BLS_wages_May_2014_NAICS325400 - Pharmaceutical and Medicine Manufacturing re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs | Supporting & Related Material | Background Material | 2016-08-31T04:00:00Z | 2016 | 8 | 2016-08-31T14:36:09Z | 0 | 0 | 09000064821b7bb6 | |||
| FDA-2005-N-0464-0234 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | Rule | Final Rule | 2016-08-31T04:00:00Z | 2016 | 8 | 2016-08-31T04:00:00Z | 2016-08-31T14:21:07Z | 2016-20471 | 0 | 0 | 09000064821b68af | |
| FDA-2005-N-0464-0232 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability | Notice | NAD-Notice of Availability of Data | 2009-06-01T04:00:00Z | 2009 | 6 | 2009-06-01T04:00:00Z | 2009-06-02T03:59:59Z | 2010-08-13T15:19:06Z | E9-12743 | 0 | 0 | 09000064809c1db8 |
| FDA-2005-N-0464-0231 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Guideline re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability | Other | Guidance | 2009-06-01T04:00:00Z | 2009 | 6 | 2009-06-01T04:00:00Z | 2016-12-08T18:55:55Z | 0 | 0 | 09000064809c15da | ||
| FDA-2005-N-0464-0230 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Notice of Availability of Data re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability | Notice | Notice of Availability | 2009-06-01T04:00:00Z | 2009 | 6 | 2009-06-01T04:00:00Z | 2009-06-02T03:59:59Z | 2020-10-10T01:01:27Z | E9-12743 | 0 | 0 | 09000064809c0c71 |
| FDA-2005-N-0464-0233 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing | Other | Guidance | 2009-05-28T04:00:00Z | 2009 | 5 | 2009-05-28T04:00:00Z | 2020-10-10T01:01:01Z | 0 | 0 | 09000064809c1ad2 | ||
| FDA-2005-N-0464-0229 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Compressed Gas Association - Supplement Comment [re FDA-2005-N-0464-0080.1] | Other | SUP-Supplement | 2009-04-16T04:00:00Z | 2009 | 4 | 2009-04-16T04:00:00Z | 2014-12-16T22:17:42Z | 0 | 0 | 090000648095560b | ||
| FDA-2005-N-0464-0222 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Hospira Inc. - "The Proposed Changes to NDC System Legacy NDC Numbers and Compliance " (Thomas F. Willer) - Testimony | Other | TS-Testimony | 2009-04-15T04:00:00Z | 2009 | 4 | 2009-04-15T04:00:00Z | 2017-01-18T17:36:54Z | 0 | 0 | 0900006480450c46 | ||
| FDA-2005-N-0464-0223 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Perrigo - "Experience with NDC Numbers" - Testimony | Other | TS-Testimony | 2009-04-15T04:00:00Z | 2009 | 4 | 2009-04-15T04:00:00Z | 2017-01-18T17:38:31Z | 0 | 0 | 0900006480450c48 | ||
| FDA-2005-N-0464-0224 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Consumer Healthcare Products Association (CHPA) - ""FDA Public Meeting – Proposed Changes to the National Drug Code (NDC) Number System" (Paul J. Larsen) - Testimony | Other | TS-Testimony | 2009-04-15T04:00:00Z | 2009 | 4 | 2009-04-15T04:00:00Z | 2017-01-18T17:40:20Z | 0 | 0 | 0900006480450c4a | ||
| FDA-2005-N-0464-0226 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Guidance for Industry Providing Regulatory Submissions in Electronic Format -Drug Establishment Registration and Drug Listing | Other | GDL-Guidance (Supporting and Related Materials) | 2009-04-15T04:00:00Z | 2009 | 4 | 2009-04-15T04:00:00Z | 2019-10-17T19:56:23Z | 0 | 0 | 0900006480667d76 | ||
| FDA-2005-N-0464-0225 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | AABB - "National Drug Codes for HCT/Ps" (M. Allene Carr-Greer) - Testimony | Other | TS-Testimony | 2009-04-15T04:00:00Z | 2009 | 4 | 2009-04-15T04:00:00Z | 2017-01-18T17:41:41Z | 0 | 0 | 0900006480450c4f | ||
| FDA-2005-N-0464-0220 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Notice re Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing | Notice | General Notice | 2008-10-23T04:00:00Z | 2008 | 10 | 2016-12-08T19:05:18Z | E8-25338 | 0 | 0 | 090000648077419a | ||
| FDA-2005-N-0464-0150 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Shipping Label re Comment from Bristol-Myers Squibb Company | Supporting & Related Material | Transmittals | 2008-09-12T04:00:00Z | 2008 | 9 | 2016-11-17T18:18:40Z | 0 | 0 | 0900006480450d18 | |||
| FDA-2005-N-0464-0073 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Background Material re The Compressed Gas Assaciation (CCA) and the Gases and Welding Distributors Association (GAWDA) | Supporting & Related Material | Background Material | 2008-09-10T04:00:00Z | 2008 | 9 | 2017-08-14T19:23:12Z | 0 | 0 | 0900006480450c6f | |||
| FDA-2005-N-0464-0030 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Request Extension of Comment Period from Compressed Gas Association | Other | EXT-Request for Extension Comment Due Date | 2008-09-09T04:00:00Z | 2008 | 9 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2017-07-21T16:15:19Z | 0 | 0 | 0900006480450c0c | |
| FDA-2005-N-0464-0034 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Request for Extension re Comment from L. Perrigo Company | Other | Request for Extension | 2008-09-09T04:00:00Z | 2008 | 9 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2016-12-13T20:38:04Z | 0 | 0 | 0900006480450c13 | |
| FDA-2005-N-0464-0033 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Request for Extension re Comment from Consumer Healthcare Products Association (CHPA) | Other | Request for Extension | 2008-09-09T04:00:00Z | 2008 | 9 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2017-08-14T20:26:17Z | 0 | 0 | 0900006480450c12 | |
| FDA-2005-N-0464-0022 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Notice of Data Availability re Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing; Availability | Notice | Notice of Data Availability | 2008-07-11T04:00:00Z | 2008 | 7 | 2008-07-11T04:00:00Z | 2008-09-10T03:59:59Z | 2024-11-12T04:16:53Z | E8-15801 | 1 | 0 | 090000648066791e |
| FDA-2005-N-0464-0021 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Notice of Extension re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; ReOpening of Comment Period | Proposed Rule | Extension of Comment Period | 2007-02-08T05:00:00Z | 2007 | 2 | 2007-02-07T05:00:00Z | 2007-02-27T04:59:59Z | 2016-11-10T15:32:42Z | 0 | 0 | 0900006480450d0d | |
| FDA-2005-N-0464-0020 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Letter from FDA/CDER Response to National Committee on Vital | Other | Letter(s) | 2007-01-29T05:00:00Z | 2007 | 1 | 2016-12-13T21:15:43Z | 0 | 0 | 0900006480450ca3 | |||
| FDA-2005-N-0464-0015 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | See FDA-2005-N-0464-0014 | Supporting & Related Material | TR-Transcript | 2007-01-12T05:00:00Z | 2007 | 1 | 2009-04-15T23:58:47Z | 0 | 0 | 0900006480450c43 | |||
| FDA-2005-N-0464-0014 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Transcript of Public Meeting: Proposed Changes to the National Drug Code (NDC) System, December 11, 2006 | Other | TR-Transcript | 2007-01-12T05:00:00Z | 2007 | 1 | 2017-07-24T15:11:28Z | 0 | 0 | 0900006480450c42 | |||
| FDA-2005-N-0464-0016 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | FDA/CDER - "Proposed Revised 21 CFR 207 Electronic Drug Registration and Listing Systems (e-DRLS)" - Testimony | Other | TS-Testimony | 2007-01-12T05:00:00Z | 2007 | 1 | 2017-01-18T17:37:35Z | 0 | 0 | 0900006480450c44 | |||
| FDA-2005-N-0464-0017 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Testimony re FDA-2005-N-0464-0016 | Supporting & Related Material | Testimony | 2007-01-12T05:00:00Z | 2007 | 1 | 2016-12-13T20:44:03Z | 0 | 0 | 0900006480450c45 | |||
| FDA-2005-N-0464-0008 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Notice of Extension re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period | Proposed Rule | Extension of Comment Period | 2006-10-31T05:00:00Z | 2006 | 10 | 2006-10-30T05:00:00Z | 2007-01-27T04:59:59Z | 2016-12-19T17:17:44Z | 0 | 0 | 0900006480450c15 | |
| FDA-2005-N-0464-0006 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process | Supporting & Related Material | REF-Reference (internal unless indicated) | 2006-09-08T04:00:00Z | 2006 | 9 | 2017-07-24T14:15:25Z | 0 | 0 | 0900006480450c08 | |||
| FDA-2005-N-0464-0005 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process | Supporting & Related Material | REF-Reference (internal unless indicated) | 2006-09-08T04:00:00Z | 2006 | 9 | 2017-07-24T14:17:07Z | 0 | 0 | 0900006480450c07 | |||
| FDA-2005-N-0464-0007 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process | Supporting & Related Material | REF-Reference (internal unless indicated) | 2006-09-08T04:00:00Z | 2006 | 9 | 2017-07-24T14:12:42Z | 0 | 0 | 0900006480450c09 | |||
| FDA-2005-N-0464-0002 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 201-300) | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2006-08-23T04:00:00Z | 2006 | 8 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2017-08-15T14:33:55Z | 0 | 0 | 0900006480450bee | |
| FDA-2005-N-0464-0001 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 301-319) | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2006-08-23T04:00:00Z | 2006 | 8 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2017-08-15T14:32:51Z | 0 | 0 | 0900006480450bce | |
| FDA-2005-N-0464-0003 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 1-100) | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2006-08-23T04:00:00Z | 2006 | 8 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2017-08-15T14:35:39Z | 0 | 0 | 0900006480450bf2 | |
| FDA-2005-N-0464-0004 | FDA | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 101-200) | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2006-08-23T04:00:00Z | 2006 | 8 | 2006-08-23T04:00:00Z | 2006-11-28T04:59:59Z | 2016-03-14T19:19:42Z | 0 | 0 | 0900006480450bf3 |
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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);