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withdrawn,object_id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-2009-P-0272-0003,FDA,FDA-2009-P-0272,"FDA/CDER Response to Sanofi-aventis, U.S., LLC - Petition Partial Approval and Denial",Other,PPAD-Petition Partial Approval and Denial,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2013-07-27T23:02:09Z,,0,0,0900006480a68fe7
FDA-1995-S-0036-0109,FDA,FDA-1995-S-0036,"Report 38 - Baylor College of Medicine Public Disclosure on IND 100,681",Other,RPT-Report,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2013-07-27T23:02:32Z,,0,0,0900006480a6b5ec
FDA-2009-P-0598-0001,FDA,FDA-2009-P-0598,James Matthew Weber - Citizen Petition,Other,CP-Citizen Petition,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2012-03-06T19:35:08Z,,0,0,0900006480a74a4d
FDA-2004-D-0123-0004,FDA,FDA-2004-D-0123,See FDA-2004-D-0123-0006,Supporting & Related Material,Background Material,2009-12-31T05:00:00Z,2009,12,,,2015-01-21T02:54:57Z,,0,0,0900006480a74ac3
FDA-2009-P-0298-0007,FDA,FDA-2009-P-0298,"FDA/CFSAN Interim Response to OVOS Natural Health, Inc. (Ullman, Shapiro & Ullman, LLP) - Letter",Other,LET-Letter,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2013-08-11T04:36:59Z,,0,0,0900006480a69fe6
FDA-2009-P-0598-0002,FDA,FDA-2009-P-0598,Acknowledgement Letter to James Matthew Weber,Other,ACK-Acknowledgement Letter,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2013-08-11T01:31:47Z,,0,0,0900006480a74a4e
FDA-2008-D-0525-0013,FDA,FDA-2008-D-0525,New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products:  Guidance for Industry,Other,Guidance,2009-12-31T05:00:00Z,2009,12,2009-12-31T05:00:00Z,,2024-11-07T22:12:12Z,,1,0,0900006480a77652
FDA-2009-N-0592-0004,FDA,FDA-2009-N-0592,"Reference 3 - ‘‘National Research Act, Title II (Public Law 93–348, July 12, 1974)""  - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T04:00:30Z,,0,0,0900006480a733d4
FDA-2008-N-0546-0009,FDA,FDA-2008-N-0546,Agency Information Collection Activities; Proposed Collection; Comment Request; Pet Food Early Warning Recall Rational Questionnaire as Part of the MedWatchPlus,Notice,N-Notice,2009-12-30T05:00:00Z,2009,12,2009-12-30T05:00:00Z,2010-01-30T04:59:59Z,2009-12-30T17:57:40Z,E9-30872,0,0,0900006480a741c2
FDA-2009-N-0664-0131,FDA,FDA-2009-N-0664,Medical Device Interoperability; Public Workshop,Notice,NM-Notice of Meeting,2009-12-30T05:00:00Z,2009,12,2009-12-30T05:00:00Z,,2009-12-30T17:44:57Z,E9-30871,0,0,0900006480a740cd
FDA-2009-N-0592-0002,FDA,FDA-2009-N-0592,"Reference 1 - ‘‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10,  Vol. 2, pp. 181–182. Office, 1949"" - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T03:57:45Z,,0,0,0900006480a7336d
FDA-2009-N-0664-0130,FDA,FDA-2009-N-0664,Advisory Committees; Tentative Schedule of Meetings for 2010,Notice,N-Notice,2009-12-30T05:00:00Z,2009,12,2009-12-30T05:00:00Z,,2009-12-30T17:39:27Z,E9-30973,0,0,0900006480a74087
FDA-2009-N-0592-0003,FDA,FDA-2009-N-0592,"Reference 2 - ""World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects"" - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T03:59:28Z,,0,0,0900006480a733cd
FDA-2009-N-0592-0005,FDA,FDA-2009-N-0592,"Reference 4 - ‘‘National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ‘‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’’ - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T04:01:40Z,,0,0,0900006480a7340b
FDA-2009-N-0664-0132,FDA,FDA-2009-N-0664,Second Annual Sentinel Initiative Public Workshop,Notice,NM-Notice of Meeting,2009-12-30T05:00:00Z,2009,12,2009-12-30T05:00:00Z,,2009-12-30T17:49:10Z,E9-30971,0,0,0900006480a740d2
FDA-2009-P-0282-0003,FDA,FDA-2009-P-0282,"FDA/CDRH to Mr. David S. Smith (Pepper Hamilton, LLP)",Other,LET-Letter,2009-12-30T05:00:00Z,2009,12,2009-12-30T05:00:00Z,,2013-07-27T23:03:28Z,,0,0,0900006480a7444f
FDA-2009-D-0461-0015,FDA,FDA-2009-D-0461,See FDA-2009-D-0461-0026,Supporting & Related Material,,2009-12-30T00:00:00Z,2009,12,,,2013-07-29T17:10:22Z,,0,1,0900006480a70e27
FDA-2009-P-0597-0008,FDA,FDA-2009-P-0597,"Tab 13/Exhibit 13 - ""National Asthma Education and Prevention Program, National Institutes of Health, The NAEPP Expert Panel Report 3, Summary Report 2007: Guidelines for the Diagnosis and Management of Asthma (2007)"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:48Z,,0,0,0900006480a6c989
FDA-2009-P-0597-0009,FDA,FDA-2009-P-0597,"Tab 15/Exhibit 15 - ""American Lung Association, Epidemiology & Statistics Unit, Research Program Services Division, Trends in Asthma Morbidity and Mortality (April 2009)"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:49Z,,0,0,0900006480a6c98d
FDA-2009-N-0592-0001,FDA,FDA-2009-N-0592,Informed Consent Elements,Proposed Rule,NPR-Notice of Proposed Rule-Making,2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,2010-03-02T04:59:59Z,2011-06-11T16:28:10Z,E9-30751,0,0,0900006480a7316e
FDA-2009-P-0597-0016,FDA,FDA-2009-P-0597,"Tab 29/Exhibit 29 - ""Approved Labeling, Prescribing Information, Advair HFA"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:59Z,,0,0,0900006480a6caf3
FDA-2009-P-0597-0024,FDA,FDA-2009-P-0597,"Tab 57/Exhibit 57 - ""PQRI Profile Comparisons Working Group, Minutes of Teleconference on February 16, 2005 "" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:10Z,,0,0,0900006480a6cd2b
FDA-2009-P-0597-0026,FDA,FDA-2009-P-0597,"Tab 77/Exhibit 77 - ""FDA/CDER Response to Hill Dermaceuticals, Inc., March 25, 2009, re Docket NID FDA-2004-P-0215"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,BKG-Background Material,2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:13Z,,0,0,0900006480a6cdd0
FDA-2009-P-0597-0029,FDA,FDA-2009-P-0597,"Tab 81/Exhibit 81 - ""What Do Cascade Impaction Measurements Tell Us: In Vitro Aspects, IPAC-RS Conference, November 6-8, 2006"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:19Z,,0,0,0900006480a6ce7f
FDA-2009-P-0597-0004,FDA,FDA-2009-P-0597,"Tab 7/Exhibit 7 - ""Infectious Diseases Society of America to FDA/CDER, November 14, 2007"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:43Z,,0,0,0900006480a6c948
FDA-2009-P-0597-0022,FDA,FDA-2009-P-0597,"Tab 54/Exhibit 54 - ""Thomas, et al., Inhaled Corticosteroids for Asthma: Impact of Practice Level Device Switching on Asthma Controls"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:07Z,,0,0,0900006480a6ccd6
FDA-2009-P-0597-0011,FDA,FDA-2009-P-0597,"Addendum - ""Volume II of III - Table of Exhibits 21-50"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:52Z,,0,0,0900006480a6c9a2
FDA-2009-P-0597-0027,FDA,FDA-2009-P-0597,"Tab 78/Exhibit 78 - ""FDA Response to McGuire Woods LLP, GlaxoSmithKline, Frommer Lawrence & Haug, LLP February 22, 2006"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:15Z,,0,0,0900006480a6cdd1
FDA-2009-P-0597-0014,FDA,FDA-2009-P-0597,"Tab 27/Exhibit 27 - ""Approved Labeling, Prescribing Information, Flovent HFA"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:56Z,,0,0,0900006480a6caf0
FDA-2009-P-0597-0017,FDA,FDA-2009-P-0597,"Tab 30/Exhibit 30 - ""FDA/CDER Response to Alza Corporation, January 28, 2005, re Docket IDs 2004P-0506/CP1, 2004P-0472/CP1,2004P-0540/CP1, and 2004P-340/CP1"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:00Z,,0,0,0900006480a6caf4
FDA-2009-P-0597-0019,FDA,FDA-2009-P-0597,"Tab 32/Exhibit 32 - ""FDA/CDER Response to Wyeth-Ayerst Research, March 1, 1999, re Docket No. 97P-0386/CP1"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,BKG-Background Material,2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:03Z,,0,0,0900006480a6cb3c
FDA-2009-P-0597-0030,FDA,FDA-2009-P-0597,"Tab 84/Exhibit 84 - ""Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Pediatric Advisory Committee, December 10-11, 2008, Transcript"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:20Z,,0,0,0900006480a6cf5e
FDA-2009-P-0597-0031,FDA,FDA-2009-P-0597,Acknowledgement Letter to GlaxoSmithKline,Other,ACK-Acknowledgement Letter,2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,,2013-08-11T03:05:59Z,,0,0,0900006480a6dd07
FDA-2009-N-0393-0012,FDA,FDA-2009-N-0393,"Reference 6 - ""U.S. Food and Drug Administration, Acrylamide in Food"" - [Acrylamide in Food; Request for Comments and for Scientific Data and Information]",Supporting & Related Material,BKG- Background Material (internal references),2009-12-29T05:00:00Z,2009,12,,,2009-12-29T19:57:39Z,,0,0,0900006480a11c83
FDA-2009-P-0597-0003,FDA,FDA-2009-P-0597,"Tab 1/Exhibit 1 - ""FDA/CDER Response to King Pharmaceuticals, July 29, 2009, re Docket IDs FDA-2007-P-0128 and FDA-2009-P-0040"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:41Z,,0,0,0900006480a6c930
FDA-2009-P-0597-0005,FDA,FDA-2009-P-0597,"Tab 10/Exhibit 10 - ""PQRI Meeting Objective and Agenda (February 2005) "" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:44Z,,0,0,0900006480a6c985
FDA-2009-P-0597-0007,FDA,FDA-2009-P-0597,"Tab 12/Exhibit 12 - ""National Vital Statistics, Deaths: Final Data for 2006, Volume 57 Report 14 (2009)"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:47Z,,0,0,0900006480a6c988
FDA-2009-P-0597-0010,FDA,FDA-2009-P-0597,"Tab 17/Exhibit 17 - ""National Institutes of Health, National Heart, Lung, and Blood Institute, Morbidity and Mortality: 2007 Chart Book on Cardiovascular, Lung, and Blood Diseases (2007)"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:51Z,,0,0,0900006480a6c99b
FDA-2009-D-0591-0001,FDA,FDA-2009-D-0591,Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions;Availability,Notice,NAD-Notice of Availability of Data,2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,,2009-12-29T14:32:34Z,E9-30750,0,0,0900006480a7313d
FDA-2009-P-0597-0021,FDA,FDA-2009-P-0597,"Tab 52/Exhibit 52 - ""Approved Labeling, Prescribing and Patient Information, Relenza Diskhaler"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:06Z,,0,0,0900006480a6ccd3
FDA-2009-D-0591-0002,FDA,FDA-2009-D-0591,Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions,Other,GDL-Guidance (Supporting and Related Materials),2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,,2024-11-07T22:11:11Z,,1,0,0900006480a73756
FDA-2009-P-0597-0028,FDA,FDA-2009-P-0597,"Tab 80/Exhibit 80 - ""Clinical Relevance on in Vitro Particle Sizing Data, IPAC-RS Conference, November 6-8, 2006"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:17Z,,0,0,0900006480a6ce7a
FDA-2009-P-0597-0006,FDA,FDA-2009-P-0597,"Tab 11/Exhibit 11 - ""American Lung Association, Epidemiology & Statistics Unit, Research Program Services Division, Trends in Asthma Morbidity and Mortality (2009)"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:45Z,,0,0,0900006480a6c986
FDA-2009-P-0597-0020,FDA,FDA-2009-P-0597,"Addendum - ""Volume III of III - Table of Exhibits 51-94"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:04Z,,0,0,0900006480a6ccd0
FDA-2009-P-0597-0025,FDA,FDA-2009-P-0597,"Tab 61/Exhibit 61 - ""The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues, Presented at OINDP Subcommittee of Advisory Committee for Pharmaceutical Science, July 2001 "" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:11Z,,0,0,0900006480a6cd2f
FDA-2009-P-0597-0001,FDA,FDA-2009-P-0597,GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition,Other,CP-Citizen Petition,2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,,2019-01-30T20:17:16Z,,0,0,0900006480a6c85b
FDA-2009-P-0597-0002,FDA,FDA-2009-P-0597,"Addendum - ""Volume I of III - Table of Exhibits 1-20"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:40Z,,0,0,0900006480a6c92f
FDA-2009-P-0597-0013,FDA,FDA-2009-P-0597,"Tab 26/Exhibit 26 - ""Approved Labeling, Prescribing Information, Flovent Diskus"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:55Z,,0,0,0900006480a6caee
FDA-2009-P-0597-0015,FDA,FDA-2009-P-0597,"Tab 28/Exhibit 28 - ""Approved Labeling, Prescribing Information, Advair Diskus"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,BKG-Background Material,2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:57Z,,0,0,0900006480a6caf1
FDA-2009-P-0597-0018,FDA,FDA-2009-P-0597,"Tab 31/Exhibit 31 - ""FDA/CDER Response to Warner Chilcott, May 1, 2009, re Docket ID FDA-2008-P-0586"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:01Z,,0,0,0900006480a6cb3a
FDA-2009-P-0597-0023,FDA,FDA-2009-P-0597,"Tab 56/Exhibit 56 - ""FDA/CDER Response to Ropes & Gray (AstraZeneca,LP), November, 18, 2008, re Docket ID FDA-2006-P-0073"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:43:08Z,,0,0,0900006480a6cd2a
FDA-2009-P-0597-0012,FDA,FDA-2009-P-0597,"Tab 25/Exhibit 25 - ""Approved Labeling, Prescribing Information, Servent Diskus"" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition]",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-29T05:00:00Z,2009,12,,,2009-12-30T00:42:53Z,,0,0,0900006480a6caed
FDA-1996-P-0383-0001,FDA,FDA-1996-P-0383,Fuisz Technologies Ltd - Citizen Petition,Other,CP-Citizen Petition,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2009-12-28T20:30:15Z,,0,0,0900006480506ffd
FDA-1996-P-0383-0002,FDA,FDA-1996-P-0383,Fuisz Technologies Ltd - Letter,Other,LET-Letter,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2009-12-28T20:30:17Z,,0,0,0900006480507008
FDA-2009-D-0600-0001,FDA,FDA-2009-D-0600,Draft Guidance for Industry on Tobacco Health Document Submission; Availability,Notice,Notice of Availability,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,2010-01-23T04:59:59Z,2016-09-09T14:32:45Z,E9-30657,0,0,0900006480a72053
FDA-1984-P-0333-0001,FDA,FDA-1984-P-0333,Petition Approval from Center for Drugs and Biologics to Sterling Drug Inc,Other,Approval,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2022-05-17T20:03:37Z,,0,0,09000064805a9401
FDA-1996-P-0383-0004,FDA,FDA-1996-P-0383,Acknowledgement Letter to Fuisz Technologies LTD,Other,ACK-Acknowledgement Letter,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2009-12-28T20:30:21Z,,0,0,0900006480a72ac2
FDA-1996-P-0383-0003,FDA,FDA-1996-P-0383,Fuisz Technologies Ltd. - Withdrawal,Other,CP-Citizen Petition,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2013-07-27T21:20:27Z,,0,0,090000648050700a
FDA-2009-N-0665-0077,FDA,FDA-2009-N-0665,New Animal Drugs; Change of Sponsor; Isoflurane,Rule,Final Rule,2009-12-28T05:00:00Z,2009,12,,,2013-07-09T18:25:09Z,E9-30590,0,0,0900006480a72080
FDA-1984-P-0333-0002,FDA,FDA-1984-P-0333,Acknowledgement Letter from Dockets Management Branch to Sterling Drug Inc,Other,Acknowledgement Letter/Receipt,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2022-05-18T15:15:25Z,,0,0,0900006480a72b74
FDA-2009-D-0600-0002,FDA,FDA-2009-D-0600,Draft Guidance for Industry on Tobacco Health Document Submission - Guidance,Other,Guidance,2009-12-28T05:00:00Z,2009,12,2009-12-28T05:00:00Z,,2024-11-07T22:13:38Z,,1,0,0900006480a71ffb
FDA-2009-Q-0301-0014,FDA,FDA-2009-Q-0301,"Section B - ""Summary of Scientific Basis for Petition, (Summary 12.18 Rev.)"" - [Nestle Infant Nutrition/Gerber Products Company - Qualified Health Claim Petition] re FDA-2009-Q-0301-0002",Supporting & Related Material,CP-Citizen Petition (Supporting & Related Materials),2009-12-23T05:00:00Z,2009,12,,,2009-12-23T06:37:23Z,,0,0,0900006480a7006a
FDA-2009-P-0297-0003,FDA,FDA-2009-P-0297,AllerQuest LLC to FDA - Withdrawal of Petition,Other,WDL-Withdrawal,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2013-07-27T23:03:06Z,,0,0,0900006480a7087b
FDA-2002-D-0223-0003,FDA,FDA-2002-D-0223,An Acceptable Circular of Information for the Use of Human Blood and Blood Components - Level 2 Guidance,Other,GDL-Guidance (Supporting and Related Materials),2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2024-11-07T22:12:43Z,,1,0,0900006480a700ff
FDA-2009-N-0664-0129,FDA,FDA-2009-N-0664,Gastrointestinal Drugs Advisory Committee Notice of Meeting,Notice,NM-Notice of Meeting,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2009-12-23T19:25:45Z,E9-30442,0,0,0900006480a704a2
FDA-2009-P-0305-0001,FDA,FDA-2009-P-0305,Hygeia II Medical Group Inc. - Citizen Petition,Other,CP-Citizen Petition,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2020-05-05T14:43:19Z,,0,0,09000064809e79c6
FDA-2009-P-0305-0002,FDA,FDA-2009-P-0305,Acknowledgement Letter to Hygeia II Medical Group Inc.,Other,ACK-Acknowledgement Letter,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2009-12-23T15:29:49Z,,0,0,09000064809e79c9
FDA-1987-P-0230-0002,FDA,FDA-1987-P-0230,FDA/Center for Drugs and Biologics - Petition Approval,Other,PAV-Petition Approval,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2013-07-27T20:47:57Z,,0,0,090000648046d7d3
FDA-2009-P-0305-0003,FDA,FDA-2009-P-0305,FDA/Center for Devices and Radiological Health Interim Response to  Hygeia II Medical Group Inc.,Other,LET-Letter,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2013-08-11T01:31:35Z,,0,0,0900006480a6b1c4
FDA-1987-P-0230-0003,FDA,FDA-1987-P-0230,Acknowledgement Letter to Sidmak Laboratories Inc,Other,ACK-Acknowledgement Letter,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2009-12-23T17:23:52Z,,0,0,0900006480a707a1
FDA-2008-D-0399-0006,FDA,FDA-2008-D-0399,International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions  Annex 5: Disintegration Test General Chapter,Notice,NAD-Notice of Availability of Data,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2009-12-23T19:06:42Z,E9-30441,0,0,0900006480a70631
FDA-2008-D-0399-0007,FDA,FDA-2008-D-0399,"Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 5 Disintegration Test General Chapter - Guidance for Industry",Other,GDL-Guidance (Supporting and Related Materials),2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2024-11-12T04:49:00Z,,1,0,0900006480a70857
FDA-1987-P-0230-0001,FDA,FDA-1987-P-0230,"Sidmak Laboratories, Inc - Citizen Petition",Other,CP-Citizen Petition,2009-12-23T05:00:00Z,2009,12,2009-12-23T05:00:00Z,,2013-07-27T20:47:57Z,,0,0,090000648046d7d2
FDA-1975-N-0012-0025,FDA,FDA-1975-N-0012,"Tab E - ""Alcavis International, Inc., Letter to FDA, March 18, 2003"" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:35:48Z,,0,0,0900006480a4d2b1
FDA-1975-N-0012-0033,FDA,FDA-1975-N-0012,"Tab M - ""Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, October 4, 2006"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:57:54Z,,0,0,0900006480a4d4e9
FDA-1975-N-0012-0029,FDA,FDA-1975-N-0012,"Tab I - ""Alcavis International, Inc. Letter to FDA, July 1, 2003"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:51:54Z,,0,0,0900006480a4d497
FDA-1975-N-0012-0028,FDA,FDA-1975-N-0012,"Tab H - ""Alcavis International, Inc. Letter to FDA, June 17, 2003"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:50:56Z,,0,0,0900006480a4d459
FDA-1975-N-0012-0027,FDA,FDA-1975-N-0012,"Tab G - ""Alcavis International, Inc. Letter to FDA, June 5, 2003"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:50:16Z,,0,0,0900006480a4d355
FDA-1975-N-0012-0024,FDA,FDA-1975-N-0012,"Tab D - ""Alcavis International, Inc., Letter to FDA, December 20, 2002"" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:34:25Z,,0,0,0900006480a4d2af
FDA-1975-N-0012-0036,FDA,FDA-1975-N-0012,"Index of Select Scientific References Cited - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing]  re FDA-1975-N-0013-0018",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-10-27T17:29:30Z,,0,0,0900006480a6f8fa
FDA-1975-N-0012-0034,FDA,FDA-1975-N-0012,"Tab N - ""Alcavis International, Inc. (Alston & Bird, LLP) Supplement, February 6, 2009"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T21:00:16Z,,0,0,0900006480a4d7b5
FDA-2009-D-0588-0002,FDA,FDA-2009-D-0588,Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents - Guidance,Other,GDL-Guidance (Supporting and Related Materials),2009-12-22T05:00:00Z,2009,12,2009-12-22T05:00:00Z,,2024-11-07T22:11:18Z,,1,0,0900006480a6f5bc
FDA-2009-D-0013-0005,FDA,FDA-2009-D-0013,International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Guidance,Other,GDL-Guidance (Supporting and Related Materials),2009-12-22T05:00:00Z,2009,12,,,2024-11-07T22:13:57Z,,1,0,0900006480a6f8f1
FDA-1975-N-0012-0021,FDA,FDA-1975-N-0012,"Tab A - Citizen Petition Filed by Robert G. Pinco, Akin, Gump, Strauss, Hauer & Feld, January 29, 1999 - (Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:31:45Z,,0,0,0900006480a4d24e
FDA-1975-N-0012-0023,FDA,FDA-1975-N-0012,"Tab C - ""FDA Response to Alcavis International, Inc., November 14, 2002"" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:33:42Z,,0,0,0900006480a4d2ac
FDA-1975-N-0012-0035,FDA,FDA-1975-N-0012,"Tab O - ""FDA/CDER Response to Alcavis International, Inc. - Petition Denial, April 24, 2009"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T21:01:01Z,,0,0,0900006480a4d7b6
FDA-1975-N-0012-0022,FDA,FDA-1975-N-0012,"Tab B - ""Citizen Petition Filed by Alcavis, International, Inc., Feburary 20, 2002"" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:32:56Z,,0,0,0900006480a4d252
FDA-1975-N-0012-0026,FDA,FDA-1975-N-0012,"Tab F - ""68 Federal Register 32003 Dated May 29, 2003"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:38:00Z,,0,0,0900006480a4d350
FDA-2009-D-0013-0004,FDA,FDA-2009-D-0013,International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions,Notice,NAD-Notice of Availability of Data,2009-12-22T05:00:00Z,2009,12,2009-12-22T05:00:00Z,,2009-12-22T16:28:44Z,E9-30326,0,0,0900006480a6f728
FDA-1975-N-0012-0031,FDA,FDA-1975-N-0012,"Tab K - ""Alcavis International, Inc. Letter to FDA, March 15, 2004"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:55:21Z,,0,0,0900006480a4d4e6
FDA-2009-N-0665-0075,FDA,FDA-2009-N-0665,Freedom of Information Summary Supplemental New Aminal Drug Application - [NADA 141-172],Supporting & Related Material,Freedom of Information Summary,2009-12-22T05:00:00Z,2009,12,,,2013-07-09T16:17:26Z,,0,0,0900006480a6f354
FDA-1975-N-0012-0030,FDA,FDA-1975-N-0012,"Tab J - ""Alcavis International, Inc. Letter to FDA, February 10, 2004"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:52:26Z,,0,0,0900006480a4d4e4
FDA-1975-N-0012-0032,FDA,FDA-1975-N-0012,"Tab L - ""Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, July 15, 2005"" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC)",Supporting & Related Material,Background Material,2009-12-22T05:00:00Z,2009,12,,,2017-11-29T20:56:35Z,,0,0,0900006480a4d4e7
FDA-2009-D-0588-0001,FDA,FDA-2009-D-0588,Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents; Availability,Notice,NAD-Notice of Availability of Data,2009-12-21T05:00:00Z,2009,12,2009-12-21T05:00:00Z,,2009-12-22T15:59:22Z,E9-30297,0,0,0900006480a6ef9e
FDA-2009-N-0665-0076,FDA,FDA-2009-N-0665,Implantation or Injectable Dosage Form New Animal Drugs: Polysulfated Glycosaminoglycan,Rule,Final Rule,2009-12-21T05:00:00Z,2009,12,,,2013-07-09T15:52:49Z,E9-30222,0,0,0900006480a6eff2
FDA-2003-M-0501-0001,FDA,FDA-2003-M-0501,Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,Notice,N-Notice,2009-12-18T05:00:00Z,2009,12,2009-12-18T05:00:00Z,,2025-04-16T19:38:47Z,03-27119,0,0,09000064804a2b25
FDA-2009-P-0405-0021,FDA,FDA-2009-P-0405,"Consumers Union and Food Animal Concerns Trust (FACT) [Multiple Names=37,170 Citizens] - Letter",Other,LET-Letter,2009-12-18T05:00:00Z,2009,12,2009-12-18T05:00:00Z,,2010-01-05T22:42:57Z,,0,0,0900006480a6e1f4
FDA-2003-M-0501-0003,FDA,FDA-2003-M-0501,DUPLICATE,Other,AAV-Approval of Application,2009-12-18T05:00:00Z,2009,12,2009-12-18T05:00:00Z,,2025-04-01T19:30:11Z,,0,0,09000064804a2b21
FDA-2009-P-0405-0022,FDA,FDA-2009-P-0405,"Enclosure 1 - ""Stop Feeding Chicken Feces to Cows!"" - [Consumers Union and Food Animal Concerns Trust (FACT) (Multiple Signatures=13,540) - Comment] re FDA-2009-P-0405-0021",Supporting & Related Material,LET-Letter (Supporting and Related Material),2009-12-18T05:00:00Z,2009,12,,,2010-01-05T22:48:59Z,,0,0,0900006480a6e2fa
FDA-2003-M-0501-0002,FDA,FDA-2003-M-0501,"Premarket Approval Response Letter from FDA CDRH to Boston Scientific Scimed, Inc.",Other,Approval,2009-12-18T05:00:00Z,2009,12,2009-12-18T05:00:00Z,,2025-04-01T19:34:05Z,,0,0,09000064804a2b1f