{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and posted_year = 2009 sorted by posted_date descending", "rows": [["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", null, "2013-07-27T23:02:09Z", null, 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", null, "2013-07-27T23:02:32Z", null, 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", null, "2012-03-06T19:35:08Z", null, 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, null, null, "2015-01-21T02:54:57Z", null, 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", null, "2013-08-11T04:36:59Z", null, 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", null, "2013-08-11T01:31:47Z", null, 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", null, "2024-11-07T22:12:12Z", null, 1, 0, "0900006480a77652"], ["FDA-2009-N-0592-0004", "FDA", "FDA-2009-N-0592", "Reference 3 - \u2018\u2018National Research Act, Title II (Public Law 93\u2013348, July 12, 1974)\"  - [Informed Consent Elements]", "Supporting & Related Material", "BKG-Background Material", "2009-12-30T05:00:00Z", 2009, 12, null, null, "2010-03-04T04:00:30Z", null, 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", null, "2009-12-30T17:44:57Z", "E9-30871", 0, 0, "0900006480a740cd"], ["FDA-2009-N-0592-0002", "FDA", "FDA-2009-N-0592", "Reference 1 - \u2018\u2018Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10,  Vol. 2, pp. 181\u2013182. Office, 1949\" - [Informed Consent Elements]", "Supporting & Related Material", "BKG-Background Material", "2009-12-30T05:00:00Z", 2009, 12, null, null, "2010-03-04T03:57:45Z", null, 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", null, "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, null, null, "2010-03-04T03:59:28Z", null, 0, 0, "0900006480a733cd"], ["FDA-2009-N-0592-0005", "FDA", "FDA-2009-N-0592", "Reference 4 - \u2018\u2018National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, \u2018\u2018The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research\u2019\u2019 - [Informed Consent Elements]", "Supporting & Related Material", "BKG-Background Material", "2009-12-30T05:00:00Z", 2009, 12, null, null, "2010-03-04T04:01:40Z", null, 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", null, "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", null, "2013-07-27T23:03:28Z", null, 0, 0, "0900006480a7444f"], ["FDA-2009-D-0461-0015", "FDA", "FDA-2009-D-0461", "See FDA-2009-D-0461-0026", "Supporting & Related Material", null, "2009-12-30T00:00:00Z", 2009, 12, null, null, "2013-07-29T17:10:22Z", null, 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, null, null, "2009-12-30T00:42:48Z", null, 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, null, null, "2009-12-30T00:42:49Z", null, 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, null, null, "2009-12-30T00:42:59Z", null, 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, null, null, "2009-12-30T00:43:10Z", null, 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, null, null, "2009-12-30T00:43:13Z", null, 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, null, null, "2009-12-30T00:43:19Z", null, 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, null, null, "2009-12-30T00:42:43Z", null, 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, null, null, "2009-12-30T00:43:07Z", null, 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, null, null, "2009-12-30T00:42:52Z", null, 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, null, null, "2009-12-30T00:43:15Z", null, 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, null, null, "2009-12-30T00:42:56Z", null, 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, null, null, "2009-12-30T00:43:00Z", null, 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, null, null, "2009-12-30T00:43:03Z", null, 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, null, null, "2009-12-30T00:43:20Z", null, 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", null, "2013-08-11T03:05:59Z", null, 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, null, null, "2009-12-29T19:57:39Z", null, 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, null, null, "2009-12-30T00:42:41Z", null, 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, null, null, "2009-12-30T00:42:44Z", null, 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, null, null, "2009-12-30T00:42:47Z", null, 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, null, null, "2009-12-30T00:42:51Z", null, 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", null, "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, null, null, "2009-12-30T00:43:06Z", null, 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", null, "2024-11-07T22:11:11Z", null, 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, null, null, "2009-12-30T00:43:17Z", null, 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, null, null, "2009-12-30T00:42:45Z", null, 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, null, null, "2009-12-30T00:43:04Z", null, 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, null, null, "2009-12-30T00:43:11Z", null, 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", null, "2019-01-30T20:17:16Z", null, 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, null, null, "2009-12-30T00:42:40Z", null, 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, null, null, "2009-12-30T00:42:55Z", null, 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, null, null, "2009-12-30T00:42:57Z", null, 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, null, null, "2009-12-30T00:43:01Z", null, 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, null, null, "2009-12-30T00:43:08Z", null, 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, null, null, "2009-12-30T00:42:53Z", null, 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", null, "2009-12-28T20:30:15Z", null, 0, 0, "0900006480506ffd"], ["FDA-1996-P-0383-0002", "FDA", "FDA-1996-P-0383", "Fuisz Technologies Ltd - 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(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, null, null, "2017-11-29T20:57:54Z", null, 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, null, null, "2017-11-29T20:51:54Z", null, 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, null, null, "2017-11-29T20:50:56Z", null, 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, null, null, "2017-11-29T20:50:16Z", null, 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, null, null, "2017-11-29T20:34:25Z", null, 0, 0, "0900006480a4d2af"], ["FDA-1975-N-0012-0036", "FDA", "FDA-1975-N-0012", "Index of Select Scientific References Cited - [Alcavis International, Inc. 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(Buchanan, Ingersoll & Rooney, PC)", "Supporting & Related Material", "Background Material", "2009-12-22T05:00:00Z", 2009, 12, null, null, "2017-11-29T21:00:16Z", null, 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", null, "2024-11-07T22:11:18Z", null, 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, null, null, "2024-11-07T22:13:57Z", null, 1, 0, "0900006480a6f8f1"], ["FDA-1975-N-0012-0021", "FDA", "FDA-1975-N-0012", "Tab A - Citizen Petition Filed by Robert G. 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(Buchanan, Ingersoll & Rooney, PC)", "Supporting & Related Material", "Background Material", "2009-12-22T05:00:00Z", 2009, 12, null, null, "2017-11-29T21:01:01Z", null, 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, null, null, "2017-11-29T20:32:56Z", null, 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, null, null, "2017-11-29T20:38:00Z", null, 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", null, "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, null, null, "2017-11-29T20:55:21Z", null, 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, null, null, "2013-07-09T16:17:26Z", null, 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, null, null, "2017-11-29T20:52:26Z", null, 0, 0, "0900006480a4d4e4"], ["FDA-1975-N-0012-0032", "FDA", "FDA-1975-N-0012", "Tab L - \"Alcavis International, Inc. 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