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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

2,474 rows where agency_id = "FDA" and posted_year = 2005 sorted by posted_date descending

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document_type 5

posted_year 1

  • 2005 · 2,474 ✖

agency_id 1

  • FDA · 2,474 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-N-0163-0001 FDA Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals FDA-2003-N-0163 FDA Notice NWL-Notice of Withdrawl 2005-12-29T05:00:00Z 2005 12 2005-12-27T05:00:00Z   2008-04-12T00:59:12Z   0 0 09000064804886b0
FDA-2005-P-0123-0001 FDA Determine that Decadron (dexamethasone USP) 1.5 mg tablet strength was not removed from the market for safety and efficacy reasons FDA-2005-P-0123 Determination That DECADRON (Dexam@thasone) Tablets, 1.5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice N-Notice 2005-12-29T05:00:00Z 2005 12 2005-12-27T05:00:00Z   2024-12-13T19:52:31Z   0 0 090000648043fc0c
FDA-2005-N-0467-0001 FDA Animal Drug User Fee Act; Public Meeting FDA-2005-N-0467 Animal Drug User Fee Act; Public Meeting Notice Meeting 2005-12-29T05:00:00Z 2005 12 2005-12-27T05:00:00Z 2006-03-27T04:59:59Z 2025-10-17T19:51:43Z E5-7876 0 0 0900006480450dda
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-0468-0002 FDA Designation of New Animal Drugs for Minor Uses or Minor Species-CLOSED FDA-2005-N-0468 Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period Proposed Rule Reopening of Comment Period 2005-12-29T05:00:00Z 2005 12 2005-12-27T05:00:00Z 2006-01-28T04:59:59Z 2016-01-12T17:25:33Z   0 0 0900006480450e0a
FDA-2005-N-0044-0002 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting. FDA-2005-N-0044 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting Notice 60 Day Proposed Information Collection 2005-12-29T05:00:00Z 2005 12 2005-12-23T05:00:00Z 2006-02-03T04:59:59Z 2025-10-17T19:03:49Z E5-7726 0 0 090000648043eafe
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-2004-P-0336-0004 FDA Health Claim Petition for Soluble Fiber from Barley FDA-2004-P-0336 FDA Notice NIR-Notice of Interim Rule 2005-12-29T05:00:00Z 2005 12 2005-12-23T05:00:00Z 2006-03-09T04:59:59Z 2008-04-12T00:49:18Z   0 0 09000064804732ca
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-2005-D-0084-0004 FDA Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Document for Maximum Recommended Level for Lead in Candy Likely To Be Consumed Frequently By Small Children, FDA-2005-D-0084 FDA Notice NAD-Notice of Availability of Data 2005-12-27T05:00:00Z 2005 12 2005-12-22T05:00:00Z 2006-03-14T04:59:59Z 2008-04-11T23:46:31Z   0 0 090000648043f444
FDA-2005-D-0084-0001 FDA Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Document for Maximum Recommended Level for Lead in Candy Likely To Be Consumed Frequently By Small Children, FDA-2005-D-0084 FDA Notice NAD-Notice of Availability of Data 2005-12-27T05:00:00Z 2005 12 2005-12-22T05:00:00Z 2006-03-14T04:59:59Z 2008-04-11T23:46:31Z   0 0 090000648043f435
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-D-0227-0001 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 Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Availability (Edition 2) Notice NAD-Notice of Availability of Data 2005-12-27T05:00:00Z 2005 12 2005-12-23T05:00:00Z 2006-12-28T04:59:59Z 2008-07-09T14:52:06Z   0 0 090000648044205e
FDA-2005-D-0084-0003 FDA Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Document for Maximum Recommended Level for Lead in Candy Likely To Be Consumed Frequently By Small Children, FDA-2005-D-0084 Supporting Document for Recommended Maximum Level for Lead in Candy Supporting & Related Material REF-Reference (internal unless indicated) 2005-12-27T05:00:00Z 2005 12     2008-04-11T23:46:31Z   0 0 090000648043f443
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-2005-N-0469-0001 FDA Agency Information Collection Activities; Reclassification Petitions for Medical Devices FDA-2005-N-0469 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices Notice 30 Day Proposed Information Collection 2005-12-27T05:00:00Z 2005 12 2005-12-23T05:00:00Z   2025-10-08T01:51:00Z E5-7804 0 0 0900006480450e3e
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-0084-0002 FDA Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Document for Maximum Recommended Level for Lead in Candy Likely To Be Consumed Frequently By Small Children, FDA-2005-D-0084 Guidance Supporting & Related Material GDL-Guidance 2005-12-27T05:00:00Z 2005 12     2008-04-11T23:46:31Z   0 0 090000648043f442
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-2005-N-0096-0001 FDA Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs FDA-2005-N-0096 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications Notice Withdrawal 2005-12-23T05:00:00Z 2005 12 2005-12-15T05:00:00Z   2025-06-19T01:11:14Z   0 0 090000648043f7c3
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-2003-N-0154-0004 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form FDA-2003-N-0154 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Research Study Complaint Form Notice 30 Day Proposed Information Collection 2005-12-23T05:00:00Z 2005 12 2005-12-16T05:00:00Z 2006-01-18T04:59:59Z 2025-03-12T13:12:59Z 05-24102 0 0 090000648048760b
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-1976-N-0027-0022 FDA OTC Nasal Decongestants FDA-1976-N-0027 Notice of Proposed Rule-Making re (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. Proposed Rule Notice of Proposed Rulemaking (NPRM) 2005-12-22T05:00:00Z 2005 12 2005-12-21T05:00:00Z 2006-03-23T04:59:59Z 2015-11-10T21:40:23Z   0 0 090000648051b798
FDA-2004-H-0391-0112 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 HF-3 Rule SET-Settlement Agreement 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:52Z   0 0 0900006480474366
FDA-2004-H-0391-0114 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 HF-3 Rule SET-Settlement Agreement 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:51Z   0 0 0900006480474368
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-P-0223-0005 FDA Request the Commissioner of Food & Drugs to Arrange Public Hearings to Cover Relevant Issues Surrounding the Proposal for OTC Sales, Distribution & Use of Hand-Held Doppler Fetoscopes-CLOSED FDA-2004-P-0223 FDA - Notice of Meeting Notice NM-Notice of Meeting 2005-12-22T05:00:00Z 2005 12 2005-12-21T05:00:00Z 2006-03-11T04:59:59Z 2009-04-21T19:53:09Z   0 0 0900006480471211
FDA-2005-D-0335-0008 FDA Draft Voluntary Hazard Analysis and Critical Control Point (HACCP) Manuals for Operators and Regulators of Retail and Food Service Establishments FDA-2005-D-0335 FDA Notice N-Notice 2005-12-22T05:00:00Z 2005 12 2005-12-21T05:00:00Z 2006-01-24T04:59:59Z 2008-04-11T23:47:17Z   0 0 0900006480448cf9
FDA-2005-N-0240-0002 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey FDA-2005-N-0240 Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey Notice 60 Day Proposed Information Collection 2005-12-22T05:00:00Z 2005 12 2005-12-21T05:00:00Z 2006-02-22T04:59:59Z 2025-10-17T19:36:13Z E5-7642 0 0 09000064804440ae
FDA-2004-H-0391-0110 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 GCF-1 Rule SET-Settlement Agreement 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:49Z   0 0 0900006480474364
FDA-2004-H-0391-0111 FDA Civil Money Penalty, Ecumed Health Group (EHG), Inc. FDA-2004-H-0391 GCF-1 Rule SET-Settlement Agreement 2005-12-22T05:00:00Z 2005 12     2008-04-12T00:37:50Z   0 0 0900006480474365
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-N-0291-0001 FDA Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices) FDA-2005-N-0291 Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices) Notice Meeting 2005-12-21T05:00:00Z 2005 12 2005-12-19T05:00:00Z   2025-10-17T19:21:08Z 05-24271 0 0 0900006480445d51
FDA-1980-N-0049-0163 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Notice Notice of Final Rule 2005-12-21T05:00:00Z 2005 12 2005-12-15T05:00:00Z   2020-09-25T13:40:57Z 05-24224 0 0 09000064805ba0aa
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-1980-N-0049-0162 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Notice General Notice 2005-12-21T05:00:00Z 2005 12 2005-12-15T05:00:00Z   2020-09-25T13:43:01Z 05-24223 0 0 09000064805ba0a9
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-D-0287-0001 FDA Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 FDA-2005-D-0287 FDA Notice NAD-Notice of Availability of Data 2005-12-15T05:00:00Z 2005 12 2005-12-13T05:00:00Z   2008-04-11T23:47:13Z   0 0 09000064804458bf
FDA-1980-N-0049-0124 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T17:26:17Z   0 0 09000064805ba082
FDA-1980-N-0049-0142 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T14:47:53Z   0 0 09000064805ba095
FDA-1980-N-0049-0144 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T13:18:41Z   0 0 09000064805ba097
FDA-1980-N-0049-0146 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:08:05Z   0 0 09000064805ba099
FDA-1980-N-0049-0156 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T19:47:03Z   0 0 09000064805ba0a3
FDA-1980-N-0049-0137 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T14:46:44Z   0 0 09000064805ba08f
FDA-1980-N-0049-0155 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:24:38Z   0 0 09000064805ba0a2
FDA-1980-N-0049-0157 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:45:00Z   0 0 09000064805ba0a4
FDA-1980-N-0049-0127 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T17:41:35Z   0 0 09000064805ba085
FDA-1980-N-0049-0154 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:21:37Z   0 0 09000064805ba0a1
FDA-1980-N-0049-0141 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T21:02:42Z   0 0 09000064805ba093
FDA-2005-D-0287-0002 FDA Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 FDA-2005-D-0287 Guideline Supporting & Related Material GDL-Guidance 2005-12-15T05:00:00Z 2005 12     2008-04-11T23:47:13Z   0 0 09000064804458f7
FDA-1980-N-0049-0139 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T14:47:11Z   0 0 09000064805ba091
FDA-1980-N-0049-0149 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T13:37:37Z   0 0 09000064805ba09c
FDA-1980-N-0049-0159 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:49:10Z   0 0 09000064805ba0a6
FDA-1980-N-0049-0126 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T17:37:32Z   0 0 09000064805ba084
FDA-1980-N-0049-0130 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T14:44:46Z   0 0 09000064805ba088
FDA-1980-N-0049-0132 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T19:44:09Z   0 0 09000064805ba08a
FDA-1980-N-0049-0134 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T20:02:28Z   0 0 09000064805ba08c
FDA-1980-N-0049-0138 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T14:46:59Z   0 0 09000064805ba090
FDA-1980-N-0049-0148 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T13:31:39Z   0 0 09000064805ba09b
FDA-2004-N-0052-0005 FDA Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations FDA-2004-N-0052 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration Recall Regulations (Guidelines) Notice Notice of Approval 2005-12-15T05:00:00Z 2005 12     2025-09-26T22:19:26Z 05-24042 0 0 090000648046e8d8
FDA-1980-N-0049-0129 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T18:54:03Z   0 0 09000064805ba087
FDA-1980-N-0049-0143 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-15T13:14:43Z   0 0 09000064805ba096
FDA-1980-N-0049-0151 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T19:51:46Z   0 0 09000064805ba09e
FDA-1980-N-0049-0153 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T20:17:12Z   0 0 09000064805ba0a0
FDA-1980-N-0049-0136 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T20:14:58Z   0 0 09000064805ba08e
FDA-1980-N-0049-0150 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-09T19:50:51Z   0 0 09000064805ba09d
FDA-2005-N-0470-0002 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling FDA-2005-N-0470 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reprocessed Single-Use Device Labeling Notice 30 Day Proposed Information Collection 2005-12-15T05:00:00Z 2005 12     2025-10-08T19:51:34Z 05-24041 0 0 0900006480450e57
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-1980-N-0049-0125 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order Supporting & Related Material Background Material 2005-12-15T05:00:00Z 2005 12     2020-09-10T17:32:47Z   0 0 09000064805ba083

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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);