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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

1,472 rows where document_type = "Other" and posted_year = 2005 sorted by posted_date descending

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  • 2005 · 1,472 ✖

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  • Other · 1,472 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-0194-0001 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Acknowledgment Letter from FDA DDM to Warren Rucker Other Acknowledgement Letter/Receipt 2005-12-30T05:00:00Z 2005 12     2018-08-13T15:51:37Z   0 0 0900006480440eae
FDA-1992-V-0009-0002 FDA Laser Light Show - CLOSED FDA-1992-V-0009 Variance Approval from FDA CDRH to Jeff Cone Studios Other Approval for Variance (VRA) 2005-12-30T05:00:00Z 2005 12     2015-09-25T18:15:32Z   0 0 0900006480525e9e
FDA-2005-N-0162-0040 FDA Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing FDA-2005-N-0162 Transcript of the November 2, 2005 Hearing Other TR-Transcript 2005-12-29T05:00:00Z 2005 12     2008-04-11T23:50:43Z   0 0 0900006480440849
FDA-2005-N-0162-0039 FDA Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing FDA-2005-N-0162 Transcript of the November 2, 2005 Hearing Other TR-Transcript 2005-12-29T05:00:00Z 2005 12     2008-04-11T23:50:47Z   0 0 0900006480440848
FDA-2005-P-0125-0003 FDA Over-the Counter Sale of Modafinil-CLOSED FDA-2005-P-0125 Letter from FDA CDER to James Salsman Other LET-Letter 2005-12-28T05:00:00Z 2005 12     2024-12-13T20:23:06Z   0 0 090000648043fc4f
FDA-2005-P-0426-0004 FDA Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired. FDA-2005-P-0426 Acknowledgment Letter from FDA DDM to Sidley Austin Brown & Wood LLP Other Acknowledgement Letter/Receipt 2005-12-28T05:00:00Z 2005 12     2025-04-25T12:54:24Z   0 0 0900006480450259
FDA-2005-P-0128-0003 FDA Petition for Amendment of Health Claim Regulations (21 C.F.R. Part 101.81) - Beta-Glucan Soluble Fiber from Whole Oat Sources and Risk of Coronary Heart Disease FDA-2005-P-0128 Letter from FDA CFSAN to Quaker Oats Company Other Letter(s) 2005-12-28T05:00:00Z 2005 12     2025-04-21T13:57:08Z   0 0 090000648043fcb6
FDA-2005-P-0426-0003 FDA Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired. FDA-2005-P-0426 Acknowledgment Letter from FDA DDM to Sidley Austin Brown & Wood LLP Other Acknowledgement Letter/Receipt 2005-12-28T05:00:00Z 2005 12     2025-04-25T12:52:39Z   0 0 0900006480450258
FDA-2005-P-0372-0003 FDA Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, By Establishing A Separate Reference Amount for Fruitcake of 43 grams (1 1/2 ounces)-CLOSED FDA-2005-P-0372 Petition Denial from FDA Associate Commissioner for Regulatory Affairs to Bell, Boyd & Lloyd LLC Other Denial 2005-12-28T05:00:00Z 2005 12     2025-03-14T19:15:35Z   0 0 090000648044b55d
FDA-2003-P-0072-0007 FDA Petition to Revoke Standards for Goat’s Milk Ice Cream and Mellorine and to Amend Standards for Ice Cream and Frozen Custard, Sherbet, and Water Ices; Petition to Amend Standards for Parmesan and Reggiano Cheese CLOSED 5/21/2008 FDA-2003-P-0072 FDA Regulations Policy & Management Staff to the Division of Dockets Management - Memorandum Other M-Memorandum 2005-12-27T05:00:00Z 2005 12     2008-06-02T19:08:15Z   0 0 0900006480482076
FDA-2003-V-0187-0003 FDA Laser Light Show FDA-2003-V-0187 FDA/CDRH to Heritage Planetarium - Approval for Variance Other VRA-Approval for Variance 2005-12-27T05:00:00Z 2005 12     2013-07-27T20:55:15Z   0 0 090000648048a9fe
FDA-2005-V-0447-0003 FDA Laser Display Device FDA-2005-V-0447 Spectronika Ltd. - Approval for Variance Other VRA-Approval for Variance 2005-12-27T05:00:00Z 2005 12     2008-10-03T18:11:05Z   0 0 0900006480450688
FDA-2000-P-0097-0003 FDA Amend Definition & Standard of Identy for Parmesan Cheese FDA-2000-P-0097 Memorandum from Regulations & Policy Management Staff to Division of Dockets Management (HFA-305), Dated 12/23/2005 Other Memorandum 2005-12-27T05:00:00Z 2005 12     2021-11-30T15:39:34Z   0 0 09000064804b828d
FDA-2005-D-0227-0002 FDA Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2) FDA-2005-D-0227 Guidance for Industry - Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2) - Final Guidance Other GDL-Guidance (Supporting and Related Materials) 2005-12-27T05:00:00Z 2005 12 2005-12-27T15:46:28Z   2024-11-12T04:12:33Z   1 0 0900006480442062
FDA-2005-P-0059-0007 FDA Remove from the Labeling for Propofol (Diprivan) the Warning that Propofol Should Be Administered Only By Persons Trained in the Administration of General Anesthesia, Rather than By Other Qualified Medical Professionals-CLOSED FDA-2005-P-0059 FDA/CDER to Williams & Connolly LLP Other LET-Letter 2005-12-27T05:00:00Z 2005 12     2008-04-12T00:07:52Z   0 0 090000648043f057
FDA-2002-N-0031-0063 FDA Animal Proteins Prohibited in Ruminant Feed FDA-2002-N-0031 The Honorable Jim Bunning to the Food and Drug Administration - Letter Other LET-Letter 2005-12-23T05:00:00Z 2005 12     2008-04-23T20:31:09Z   0 0 090000648048a4b5
FDA-2002-N-0031-0052 FDA Animal Proteins Prohibited in Ruminant Feed FDA-2002-N-0031 The Honorable John E. Peterson to the Food and Drug Administration - Letter Other LET-Letter 2005-12-23T05:00:00Z 2005 12     2008-04-23T20:25:01Z   0 0 090000648048a47f
FDA-2002-N-0031-0051 FDA Animal Proteins Prohibited in Ruminant Feed FDA-2002-N-0031 The Honorable John E. Peterson to the Food and Drug Administration - Letter Other LET-Letter 2005-12-23T05:00:00Z 2005 12     2008-04-23T20:23:27Z   0 0 090000648048a478
FDA-2004-H-0391-0113 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 FDA/DDM Other CS-Certificate of Service 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:50Z   0 0 0900006480474367
FDA-2005-P-0008-0001 FDA Number not used FDA-2005-P-0008 Number not used Other ACK-Acknowledgement Letter 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:07:27Z   0 0 090000648043e3b8
FDA-2004-H-0391-0115 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 FDA/DDM Other CS-Certificate of Service 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:51Z   0 0 0900006480474369
FDA-2005-P-0436-0003 FDA take the administrative action of clarifying, in writing,whether or not the dietary supplement VI-28 TM, as detailed in the pre-market notification filed 18 August 2005, upon importation into the US, shall be deemed adulterated under 402(f) take the administrative action of clarifying, in writing, whether or not the dietary supplment VI-28 TM, as detailed in the pre-market notification filed 18 Au FDA-2005-P-0436 number not used Other ACK-Acknowledgement Letter 2005-12-21T05:00:00Z 2005 12     2008-04-12T00:10:37Z   0 0 090000648045046d
FDA-2005-P-0057-0003 FDA Revise FDA's guidance entitled labeling for combined oral contraceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease that are consistent with those required by European Medicines Agency FDA-2005-P-0057 Acknowledgment Letter from FDA DDM to Hyman, Phelps & McNamara, P.C Other Acknowledgement Letter/Receipt 2005-12-21T05:00:00Z 2005 12     2025-04-24T16:28:00Z   0 0 090000648043ee1c
FDA-2005-P-0057-0002 FDA Revise FDA's guidance entitled labeling for combined oral contraceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease that are consistent with those required by European Medicines Agency FDA-2005-P-0057 Acknowledgment Letter from FDA DDM to Hyman, Phelps & McNamara, P.C Other Acknowledgement Letter/Receipt 2005-12-21T05:00:00Z 2005 12     2025-04-24T16:26:37Z   0 0 090000648043ee1b
FDA-2005-P-0057-0001 FDA Revise FDA's guidance entitled labeling for combined oral contraceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease that are consistent with those required by European Medicines Agency FDA-2005-P-0057 Acknowledgment Letter from FDA DDM to Hyman, Phelps & McNamara, P.C Other Acknowledgement Letter/Receipt 2005-12-21T05:00:00Z 2005 12     2025-04-24T16:25:27Z   0 0 090000648043ee10
FDA-2005-V-0452-0002 FDA Laser Pointer/Illuminator products GCP-1A. GCP-2 FDA-2005-V-0452 Acknowledgement Letter to Night Vision Equipment Company Other Acknowledgement Letter/Receipt 2005-12-21T05:00:00Z 2005 12     2025-11-06T02:29:53Z   0 0 09000064804507b5
FDA-2005-V-0452-0001 FDA Laser Pointer/Illuminator products GCP-1A. GCP-2 FDA-2005-V-0452 Duplicate - Acknowledgement Letter to Night Vision Equipment Company Other Acknowledgement Letter/Receipt 2005-12-21T05:00:00Z 2005 12     2025-11-06T02:29:00Z   0 0 09000064804507b0
FDA-2005-N-0040-0005 FDA Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting FDA-2005-N-0040 Agenda for November 17, 2005 Stakeholder Meeting Other LST-List 2005-12-20T05:00:00Z 2005 12     2008-04-11T23:49:32Z   0 0 090000648043eab4
FDA-2005-P-0133-0001 FDA ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL-CLOSED FDA-2005-P-0133 HFA-305 to Mayne Pharma (USA) Inc. Other ACK-Acknowledgement Letter 2005-12-20T05:00:00Z 2005 12     2008-04-12T00:08:30Z   0 0 090000648043fe0e
FDA-2005-P-0133-0002 FDA ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL-CLOSED FDA-2005-P-0133 HFA-305 to Mayne Pharma (USA) Inc. Other ACK-Acknowledgement Letter 2005-12-20T05:00:00Z 2005 12     2008-04-12T00:08:30Z   0 0 090000648043fe15
FDA-2005-P-0436-0001 FDA take the administrative action of clarifying, in writing,whether or not the dietary supplement VI-28 TM, as detailed in the pre-market notification filed 18 August 2005, upon importation into the US, shall be deemed adulterated under 402(f) take the administrative action of clarifying, in writing, whether or not the dietary supplment VI-28 TM, as detailed in the pre-market notification filed 18 Au FDA-2005-P-0436 HFA-305 to Vigconic (International), Ltd. Other ACK-Acknowledgement Letter 2005-12-20T05:00:00Z 2005 12     2008-04-12T00:10:37Z   0 0 0900006480450443
FDA-2005-P-0436-0002 FDA take the administrative action of clarifying, in writing,whether or not the dietary supplement VI-28 TM, as detailed in the pre-market notification filed 18 August 2005, upon importation into the US, shall be deemed adulterated under 402(f) take the administrative action of clarifying, in writing, whether or not the dietary supplment VI-28 TM, as detailed in the pre-market notification filed 18 Au FDA-2005-P-0436 HFA-305 to Vigconic (International), Ltd. Other ACK-Acknowledgement Letter 2005-12-20T05:00:00Z 2005 12     2008-04-12T00:10:37Z   0 0 090000648045046b
FDA-1999-N-0113-0174 FDA Vibrio Parahaemolyticus in molluscan shellfish public health FDA-1999-N-0113 Transcript of the August 13, 2005 Meeting Other TR-Transcript 2005-12-20T05:00:00Z 2005 12     2008-04-25T00:17:45Z   0 0 09000064804ae8c5
FDA-1999-N-0113-0175 FDA Vibrio Parahaemolyticus in molluscan shellfish public health FDA-1999-N-0113 Transcript of the August 13, 2005 Meeting Other TR-Transcript 2005-12-20T05:00:00Z 2005 12     2008-04-25T00:17:46Z   0 0 09000064804ae8c6
FDA-2005-P-0366-0002 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Acknowledgement Letter from FDA DDM to Keller and Heckman LLP Other Acknowledgement Letter/Receipt 2005-12-20T05:00:00Z 2005 12     2025-04-24T18:29:38Z   0 0 090000648044af31
FDA-2005-P-0366-0001 FDA Require that generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) meet specific criteria in order to be considered bioequivalent to Wellbutrin XL-CLOSED FDA-2005-P-0366 Acknowledgement Letter from FDA DDM to Keller and Heckman LLP Other Acknowledgement Letter/Receipt 2005-12-20T00:00:00Z 2005 12     2025-05-09T01:17:11Z   0 0 090000648044aec8
FDA-2005-P-0070-0005 FDA To change the classification of EEG electrode scurrently classified as class II and requiring 510K approvals FDA-2005-P-0070 Acknowledgment Letter from FDA DDM to Scientific Laboratory Products Other Acknowledgement Letter/Receipt 2005-12-19T05:00:00Z 2005 12     2024-12-13T15:10:16Z   0 0 090000648043f2f3
FDA-2005-P-0124-0003 FDA Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns FDA-2005-P-0124 Letter from FDA CDER to Pharmaceutical Patent Attorneys, LLC Other LET-Letter 2005-12-16T05:00:00Z 2005 12     2024-12-13T15:34:04Z   0 0 090000648043fc3d
FDA-2005-N-0281-0007 FDA FDAs Communication of Drug Safety Information; Public Hearing FDA-2005-N-0281 Agenda for December 7-8, 2005 Hearing Other LST-List 2005-12-16T05:00:00Z 2005 12     2008-04-11T23:53:34Z   0 0 0900006480444c01
FDA-2005-N-0281-0009 FDA FDAs Communication of Drug Safety Information; Public Hearing FDA-2005-N-0281 List of Attendees for 12/7-8/2005 Public Meeting Other LST-List 2005-12-16T05:00:00Z 2005 12     2008-04-11T23:53:48Z   0 0 0900006480444c17
FDA-2005-N-0281-0006 FDA FDAs Communication of Drug Safety Information; Public Hearing FDA-2005-N-0281 Agenda for December 7-8, 2005 Hearing Other LST-List 2005-12-16T05:00:00Z 2005 12     2008-04-11T23:53:36Z   0 0 0900006480444c00
FDA-2005-N-0281-0008 FDA FDAs Communication of Drug Safety Information; Public Hearing FDA-2005-N-0281 Director, Center for Drugs Evaluation and Research, FDA Other TS-Testimony 2005-12-16T05:00:00Z 2005 12     2008-04-11T23:53:31Z   0 0 0900006480444c02
FDA-2005-P-0061-0003 FDA Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup; CLOSED FDA-2005-P-0061 Letter from FDA CFSAN to Alaska Birch Syrupmakers Association Other LET-Letter 2005-12-16T05:00:00Z 2005 12     2024-12-16T21:58:23Z   0 0 090000648043f0ff
FDA-2005-N-0099-0017 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Transcript of the November 14, 2005 meeting Other TR-Transcript 2005-12-15T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f859
FDA-2005-P-0122-0002 FDA Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products FDA-2005-P-0122 Acknowledgement Letter from FDA DDM to Buchanan Ingersoll PC Other Acknowledgement Letter/Receipt 2005-12-15T05:00:00Z 2005 12     2025-04-24T14:52:02Z   0 0 090000648043fc06
FDA-2005-P-0122-0001 FDA Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products FDA-2005-P-0122 Acknowledgement Letter from FDA DDM to Buchanan Ingersoll PC Other Acknowledgement Letter/Receipt 2005-12-15T05:00:00Z 2005 12     2025-04-24T14:49:23Z   0 0 090000648043fbf1
FDA-2005-N-0040-0004 FDA Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting FDA-2005-N-0040 Transcript of November 17, 2005 Meeting Other TR-Transcript 2005-12-14T05:00:00Z 2005 12     2008-04-11T23:49:32Z   0 0 090000648043eab3
FDA-2005-N-0162-0037 FDA Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing FDA-2005-N-0162 Transcript of the November 1, 2005 Public Hearing Other TR-Transcript 2005-12-14T05:00:00Z 2005 12     2008-04-11T23:50:50Z   0 0 0900006480440836
FDA-2005-N-0040-0003 FDA Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting FDA-2005-N-0040 Transcript of November 17, 2005 Meeting Other TR-Transcript 2005-12-14T05:00:00Z 2005 12     2008-04-11T23:49:32Z   0 0 090000648043eab2
FDA-2005-N-0040-0002 FDA Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting FDA-2005-N-0040 Transcript of November 17, 2005 Meeting Other TR-Transcript 2005-12-14T05:00:00Z 2005 12     2008-04-11T23:49:32Z   0 0 090000648043eab1
FDA-1990-S-0006-0147 FDA Generic Drug Speeches & Policy & Procedure Guides FDA-1990-S-0006 Statistical Report - Month of November 2005 Other RPT-Report (outside of agency unless indicated) 2005-12-14T05:00:00Z 2005 12     2008-05-16T23:52:04Z   0 0 09000064805260ed
FDA-2005-N-0162-0038 FDA Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing FDA-2005-N-0162 Transcript of the November 1, 2005 Public Hearing Other TR-Transcript 2005-12-14T05:00:00Z 2005 12     2008-04-11T23:50:33Z   0 0 0900006480440837
FDA-2005-V-0148-0002 FDA Laser Light Show FDA-2005-V-0148 Duplicate - Acknowledgement Letter to Fullhouse Productions L.L.C. Other Acknowledgement Letter/Receipt 2005-12-14T05:00:00Z 2005 12     2025-11-06T01:19:41Z   0 0 09000064804400b1
FDA-2004-P-0154-0004 FDA To Clarify the Use of the Terms "100% Natural" & "Fat Free" In Food Product Packages-CLOSED FDA-2004-P-0154 Citizen Petition Denial Letter from FDA CFSAN to Antonio Zamora Other Denial of Petition 2005-12-14T05:00:00Z 2005 12 2005-12-12T05:00:00Z   2024-11-21T22:08:44Z   0 0 0900006480470013
FDA-2005-V-0148-0001 FDA Laser Light Show FDA-2005-V-0148 Acknowledgement Letter to Fullhouse Productions L.L.C. Other Acknowledgement Letter/Receipt 2005-12-14T05:00:00Z 2005 12     2025-11-06T01:17:41Z   0 0 09000064804400a1
FDA-2001-D-0092-0022 FDA Clinical Laboratory Improvement Amendments of 1988 FDA-2001-D-0092 Clinical Laboratory Improvement Advisory Committee Other Supplement (SUP) 2005-12-12T05:00:00Z 2005 12     2025-09-18T19:16:10Z   0 0 09000064804b8ded
FDA-2001-D-0092-0023 FDA Clinical Laboratory Improvement Amendments of 1988 FDA-2001-D-0092 Clinical Laboratory Improvement Advisory Committee Other Supplement (SUP) 2005-12-12T05:00:00Z 2005 12     2025-09-18T19:17:15Z   0 0 09000064804b8def
FDA-1976-N-0519-0008 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Acknowledgement Letter from FDA/DDM to Foley & Lardner, LLP Other Acknowledgement Letter/Receipt 2005-12-09T05:00:00Z 2005 12     2016-02-23T21:34:28Z   0 0 090000648053bd53
FDA-2005-P-0126-0003 FDA Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies; CLOSED FDA-2005-P-0126 Letter from FDA CFSAN to David J Getoff Other Letter(s) 2005-12-09T05:00:00Z 2005 12     2025-03-14T12:38:18Z   0 0 090000648043fc6d
FDA-1976-N-0519-0007 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Acknowledgement Letter from FDA/DDM to Foley & Lardner, LLP Other Acknowledgement Letter/Receipt 2005-12-09T05:00:00Z 2005 12     2016-03-08T16:10:22Z   0 0 090000648053bd52
FDA-2005-N-0099-0011 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Director, Center for Drug Evaluation and Research, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:04Z   0 0 090000648043f828
FDA-2005-N-0099-0012 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Director, Center for Drug Evaluation and Research, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f829
FDA-2005-N-0099-0005 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Agenda for November 14, 25005 FDA and Stateholders Public Meeting Other LST-List 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f822
FDA-2005-N-0099-0013 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Director, Center for Biologics Evaluation and Research, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f82a
FDA-2005-P-0062-0002 FDA Require Manufacturers to Stop Using Xylene, Toluene & Dibutyl Phthalate In Nail Polish Marketed for Children Under the Age of 14-CLOSED FDA-2005-P-0062 Acknowledgment Letter from FDA DDM to U.S. Public Interest Research Group Other Acknowledgement Letter/Receipt 2005-12-07T05:00:00Z 2005 12     2025-04-24T13:34:58Z   0 0 090000648043f11a
FDA-2005-N-0099-0015 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Deputy Commissioner for Policy, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f839
FDA-2005-N-0099-0016 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Deputy Commissioner for Policy, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f83a
FDA-2005-N-0099-0014 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Director, Center for Biologics Evaluation and Research, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f82b
FDA-2005-N-0099-0008 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Biographies for November 14, 2005 Meeting Other LST-List 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f825
FDA-2000-V-0070-0002 FDA AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light FDA-2000-V-0070 Approval for Variance from FDA to Insight Technology Inc Other Approval for Variance (VRA) 2005-12-07T05:00:00Z 2005 12     2025-08-11T21:50:52Z   0 0 09000064804b0204
FDA-2005-N-0099-0007 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Biographies for November 14, 2005 Meeting Other LST-List 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f824
FDA-2005-N-0099-0006 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Agenda for November 14, 25005 FDA and Stateholders Public Meeting Other LST-List 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f823
FDA-2005-N-0099-0009 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Deputy Commissioner for Operations, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f826
FDA-2005-P-0062-0001 FDA Require Manufacturers to Stop Using Xylene, Toluene & Dibutyl Phthalate In Nail Polish Marketed for Children Under the Age of 14-CLOSED FDA-2005-P-0062 Acknowledgment Letter from FDA DDM to U.S. Public Interest Research Group Other Acknowledgement Letter/Receipt 2005-12-07T05:00:00Z 2005 12     2025-04-24T13:33:27Z   0 0 090000648043f115
FDA-2005-N-0099-0010 FDA Prescription Drug User Fee Act (PDUFA): Public Meeting FDA-2005-N-0099 Deputy Commissioner for Operations, FDA Other TS-Testimony 2005-12-07T05:00:00Z 2005 12     2008-04-11T23:50:03Z   0 0 090000648043f827
FDA-2005-N-0281-0005 FDA FDAs Communication of Drug Safety Information; Public Hearing FDA-2005-N-0281 Embassy of France / Economic Department Other APE-Appearance Request 2005-12-06T05:00:00Z 2005 12     2008-04-11T23:53:34Z   0 0 0900006480444bec
FDA-1987-V-0006-0002 FDA Laser Lighting Effects FDA-1987-V-0006 Variance Approval Letter from FDA CDRH to Chameleon Productions Other Approval for Variance (VRA) 2005-12-06T05:00:00Z 2005 12     2023-05-01T13:29:23Z   0 0 090000648046b708
FDA-2004-H-0391-0108 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 FDA/DDM to Parties Other CS-Certificate of Service 2005-12-05T05:00:00Z 2005 12     2008-04-12T00:37:52Z   0 0 0900006480474361
FDA-2005-P-0067-0003 FDA Deny the Pre-Market Approval Applications of Mentor Corporation * Inamed Corporation for Approval of Silicone-Gel Flled Breast Implant Products-CLOSED FDA-2005-P-0067 Letter from FDA CDRH to Zuckerman Spaeder, LLP Other LET-Letter 2005-12-05T05:00:00Z 2005 12     2024-11-18T17:18:00Z   0 0 090000648043f298
FDA-2004-H-0391-0109 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 FDA/DDM to Parties Other CS-Certificate of Service 2005-12-05T05:00:00Z 2005 12     2008-04-12T00:37:52Z   0 0 0900006480474362
FDA-2004-H-0391-0106 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 Center for Devices and Radiological Health, Ecumed Health Group, Inc, Amador Reyes, Juan Carrai, Ric Other MO-Motion 2005-12-05T05:00:00Z 2005 12     2008-04-12T00:37:50Z   0 0 090000648047435f
FDA-2004-H-0391-0107 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 Administrative Law Judge Other OR-Order 2005-12-05T05:00:00Z 2005 12     2008-04-12T00:37:52Z   0 0 0900006480474360
FDA-2004-P-0471-0005 FDA Regulate the Use of Coding on Food Labels-CLOSED FDA-2004-P-0471 Citizen Petition Denial from FDA CFSAN to Bunny Abraham Other Denial of Petition 2005-12-05T05:00:00Z 2005 12 2005-11-21T05:00:00Z   2025-03-18T20:39:33Z   0 0 0900006480475c61
FDA-2005-D-0208-0002 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Draft Guidance Document Other GDL-Guidance (Supporting and Related Materials) 2005-12-02T05:00:00Z 2005 12     2008-07-18T05:20:46Z   0 0 090000648044123a
FDA-2005-H-0506-0020 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 HF-3 to TMJ Implants, Inc. Other OR-Order 2005-12-01T05:00:00Z 2005 12     2008-04-11T23:48:21Z   0 0 0900006480464430
FDA-2005-H-0506-0021 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 FDA/DDM Other CS-Certificate of Service 2005-12-01T05:00:00Z 2005 12     2008-04-11T23:48:27Z   0 0 0900006480464431
FDA-2005-H-0506-0018 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 HF-3 to TMJ Implants, Inc. Other OR-Order 2005-12-01T05:00:00Z 2005 12     2008-04-11T23:48:22Z   0 0 090000648046442e
FDA-2005-H-0506-0019 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 FDA/DDM Other CS-Certificate of Service 2005-12-01T05:00:00Z 2005 12     2008-04-11T23:48:22Z   0 0 090000648046442f
FDA-2005-P-0433-0005 FDA Amend the Regulations Governing the Labeling of Milk Products that Are Set Out In Part 131 of Title 21 of the Code of Federal Regulations-CLOSED FDA-2005-P-0433 Letter from FDA CFSAN to City of Allentown Health Bureau Other LET-Letter 2005-11-29T05:00:00Z 2005 11     2024-11-18T16:25:42Z   0 0 09000064804503dc
FDA-2003-P-0335-0004 FDA Issue A Report to the NIST, the NCWM & the Petitioner, Providing the Necessary Information, Available Only to the FDA, on Pill Weight Tolerances and/or Variations Caused by Reformulations, In Order to Allow A Proper Evaluation of the Danger to the Public Posed By Pending Changes to NIST Handbook 44 Which Would Allow the Dispensing of Pills Based Upon Weight Rather than Count In Pharmacies-CLOSED FDA-2003-P-0335 Letter from FDA CDER to Fulcrum, Inc. Other LET-Letter 2005-11-29T05:00:00Z 2005 11 2005-11-28T05:00:00Z   2024-11-20T22:10:59Z   0 0 09000064804960bb
FDA-2005-H-0506-0017 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 GCF-1, TMJ Implants, Inc. and Robert W. Christensen and Maureen K . Mooney Other MO-Motion 2005-11-29T05:00:00Z 2005 11     2008-04-11T23:48:24Z   0 0 090000648046442a
FDA-2004-G-0002-0005 FDA Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2004-G-0002 Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Other Guidance 2005-11-29T05:00:00Z 2005 11 2020-09-16T04:00:00Z   2024-11-06T23:39:58Z   1 0 090000648485cceb
FDA-2005-N-0295-0002 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 Agenda - "Assessing Consumer Perceptions of Health Claims, November 17, 2005" - Public Meeting Other LST-List 2005-11-25T05:00:00Z 2005 11     2013-08-11T02:31:58Z   0 0 0900006480446b2d
FDA-2005-N-0295-0012 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 Federal Trade Commission (FTC) (PIppolito) - "Qualified Health Claims" - [Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments] - Testimony Other TS-Testimony 2005-11-25T05:00:00Z 2005 11     2010-03-19T15:56:48Z   0 0 0900006480446b49
FDA-2005-P-0329-0002 FDA Declare that Meloxicam, Orally Disintegrating Tablets, 7.5 mg,15 mg is Suitable for Submission as an ANDA; CLOSED FDA-2005-P-0329 Acknowledgement Letter from FDA DDM to Camargo Pharmaceutical Services Other Acknowledgement Letter/Receipt 2005-11-25T05:00:00Z 2005 11     2025-04-24T12:20:39Z   0 0 09000064804486b4
FDA-2005-N-0295-0005 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 FDA/CFSAN/ONPLDS (BSchneeman) - "Scientific Review of Qualified Health Claims (QHC)" - [Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments] - Testimony Other TS-Testimony 2005-11-25T05:00:00Z 2005 11     2013-07-28T01:32:19Z   0 0 0900006480446b34
FDA-2005-P-0329-0001 FDA Declare that Meloxicam, Orally Disintegrating Tablets, 7.5 mg,15 mg is Suitable for Submission as an ANDA; CLOSED FDA-2005-P-0329 Acknowledgement Letter from FDA DDM to Camargo Pharmaceutical Services Other Acknowledgement Letter/Receipt 2005-11-25T05:00:00Z 2005 11     2025-04-24T12:19:27Z   0 0 0900006480448649
FDA-2005-N-0295-0003 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 FDA Office of the General Counsel (LNickerson) - "Legal Context of Consumer Research on Health Claims and Other Food Labeling Claims" - [Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments] - Testimony Other TS-Testimony 2005-11-25T05:00:00Z 2005 11     2013-07-27T20:43:22Z   0 0 0900006480446b2f
FDA-2005-N-0295-0007 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 FDA/CFSAN (SBradbard) - "Consumer Studies Research Overview" - [Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments] - Testimony Other TS-Testimony 2005-11-25T05:00:00Z 2005 11     2013-08-11T02:31:58Z   0 0 0900006480446b3b
FDA-2005-N-0295-0010 FDA Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments FDA-2005-N-0295 FDA, Office of Regulatory Affairs (BDerby) - "Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims" - [Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments] - Testimony Other TS-Testimony 2005-11-25T05:00:00Z 2005 11     2013-07-27T20:43:23Z   0 0 0900006480446b43

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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);