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withdrawn,object_id FDA-2002-N-0279-0027,FDA,FDA-2002-N-0279,Tab 20 - [Reference (Drug Expenditure Tables)] - Background Material,Supporting & Related Material,Reference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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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