documents

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

27 rows where docket_id = "FDA-2002-N-0279" 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 4

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2002-N-0279-0027 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 20 - [Reference (Drug Expenditure Tables)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T22:02:41Z   0 0 090000648049e6cc
FDA-2002-N-0279-0016 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 4 - [Reference (FDA to Lord, Bissell & Brook on Behalf of Apotex, Inc. Citizen Petition)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:06Z   0 0 090000648049e6c6
FDA-2002-N-0279-0024 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 14 - [Reference (Congressional Budget Office "How Increased Competition from Generic Drugs has Affected Prices and Returns in the Pharmaceutical Industry" (July 1998))] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:20Z   0 0 090000648049e6c9
FDA-2002-N-0279-0013 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 1 - [Reference "FTC Citizen Petiton"] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:06Z   0 0 090000648049e6bc
FDA-2002-N-0279-0017 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 5 - [Reference (Guidance for Industry "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients")] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:06Z   0 0 090000648049e6c7
FDA-2002-N-0279-0019 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 7 - [Reference Andrx Pharmaceuticals, Inc. v. Biovail Corporation International and Tommy Thompson, Secretary DHHS] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:07Z   0 0 090000648049e6cd
FDA-2002-N-0279-0022 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 10 - [Reference "The Patent Term Restoration Act of 1983"] (page 48, 56 and 57 Lewis A. Engman Comment)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:20Z   0 0 090000648049e6c3
FDA-2002-N-0279-0020 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 8 - [Reference "Congressional House" (Page H 6916 thru H 6921 (9/13/1982))] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:19Z   0 0 090000648049e6bf
FDA-2002-N-0279-0012 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Reference Listing - [Tab 1 thru 19 Reference Title List] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:13:53Z   0 0 090000648049e6bd
FDA-2002-N-0279-0026 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 19 - [Reference "National Health Care Expenditures Projections: 2001-2011" (Centers for Medicare & Medicaid Services - Office of the Actuary)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T22:01:17Z   0 0 090000648049e6cb
FDA-2002-N-0279-0021 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 9 - [Reference "Congressional House" (Page H 6922 thru H 6924 (9/13/1982))] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:20Z   0 0 090000648049e6c1
FDA-2002-N-0279-0014 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 2 - [Reference "Generic Drug Entry Prior to Patent Expiration" (An FTC Study (July 2002))] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:57:55Z   0 0 090000648049e6c0
FDA-2002-N-0279-0015 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 3 - [Reference (FDA to Biovail Laboratories Inc.)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:06Z   0 0 090000648049e6c4
FDA-2002-N-0279-0018 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 6 - [Reference (FDA to Beers, Korn, Arnold & Porter, McNichol, Scheineson, Frisch, Smith (Petiton Denial))] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:07Z   0 0 090000648049e6c8
FDA-2002-N-0279-0025 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 16 - [Reference "The Pediatric Exclusivity Provision - January 2001 Status Report to Congress" [DHHS/FDA]] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:49:03Z   0 0 090000648049e6ca
FDA-2002-N-0279-0023 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab 11 - [Reference (Mr. Kastenmeier Report from Judiciary Committee)] - Background Material Supporting & Related Material Reference (external attachments) 2011-11-17T05:00:00Z 2011 11     2011-11-17T21:14:20Z   0 0 090000648049e6c5
FDA-2002-N-0279-0011 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 FDA [Technical Amendment] - Notice of Final Rule Notice NFR-Notice of Final Rule 2004-03-15T05:00:00Z 2004 3 2004-03-09T05:00:00Z   2009-03-09T17:44:23Z   0 0 090000648049e7bb
FDA-2002-N-0279-0009 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab A - OMB Review (6/18/2000) [Final Rule page 1 thru 99] - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-06T05:00:00Z 2003 11     2009-03-10T13:10:24Z   0 0 090000648049e7b6
FDA-2002-N-0279-0006 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab B - [OMB Review ([Notice of Final Rule page 99 thru 121 and FDA3542a) (6/18/2003)] - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-06T05:00:00Z 2003 11     2009-03-10T13:13:07Z   0 0 090000648049e7ae
FDA-2002-N-0279-0010 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Cover Page - OMB Review (6/18/2003) - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-06T05:00:00Z 2003 11     2009-03-10T13:16:38Z   0 0 090000648049e7b9
FDA-2002-N-0279-0007 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 Tab B - [OMB Review ([Notice of Final Rule page 1 thru 98) (6/18/2003)] - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-06T05:00:00Z 2003 11     2009-03-10T13:01:39Z   0 0 090000648049e7b1
FDA-2002-N-0279-0008 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 OMB Review [Notice of Final Rule 100 thru 122 pages] (6/18/2003) - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2003-11-06T05:00:00Z 2003 11     2009-03-09T18:15:49Z   0 0 090000648049e7b4
FDA-2002-N-0279-0005 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 OMB INFORMATION COLLECTION - SUPPORTING STATEMENT Supporting & Related Material SS-Supporting Statement 2003-08-12T04:00:00Z 2003 8     2009-03-15T16:03:53Z   0 0 090000648049e7ac
FDA-2002-N-0279-0003 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 FDA - Notice of Approval Notice NAL-Notice of Approval 2003-08-12T04:00:00Z 2003 8 2003-08-07T04:00:00Z   2009-03-09T17:43:31Z   0 0 090000648049e7a9
FDA-2002-N-0279-0004 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 OMB INFORMATION COLLECTION - SUPPORTING STATEMENT Supporting & Related Material SS-Supporting Statement 2003-08-12T04:00:00Z 2003 8     2009-03-15T16:03:11Z   0 0 090000648049e7aa
FDA-2002-N-0279-0002 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 FDA - Notice of Final Rule Notice NFR-Notice of Final Rule 2003-07-01T04:00:00Z 2003 7 2003-06-12T04:00:00Z   2009-03-09T17:42:58Z   0 0 090000648049e7a5
FDA-2002-N-0279-0001 FDA Applications for FDA Approval to Market a New Drug FDA-2002-N-0279 FDA - Notice of Proposed Rule-Making Notice NPR-Notice of Proposed Rule-Making 2002-10-28T05:00:00Z 2002 10 2002-10-28T05:00:00Z 2002-12-24T04:59:59Z 2009-03-09T17:41:56Z   0 0 090000648049e6ba

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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);