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2,853 rows where agency_id = "FDA" and posted_year = 2003 sorted by posted_date descending

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  • 2003 · 2,853 ✖

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  • FDA · 2,853 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-D-0428-0003 FDA Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0428 GUIDANCE Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T00:55:43Z   0 0 09000064804a21d1
FDA-2003-D-0244-0001 FDA Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision FDA-2003-D-0244 FDA Notice NAD-Notice of Availability of Data 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-02T04:59:59Z 2008-04-12T00:55:07Z   0 0 090000648048ecd0
FDA-2003-N-0096-0001 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements for Spore-Forming Microorganisms Notice NPR-Notice of Proposed Rule-Making 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-19T09:00:11Z 03-31919 0 0 09000064804838aa
FDA-2003-D-0428-0002 FDA Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0428 GUIDANCE Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T00:55:43Z   0 0 09000064804a21cf
FDA-2002-D-0022-0003 FDA Medical Devices; Chemical Indicators Premarket Notification FDA-2002-D-0022 GUIDANCE Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T01:16:13Z   0 0 0900006480488e12
FDA-2003-D-0244-0003 FDA Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision FDA-2003-D-0244 Guidance Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T00:55:07Z   0 0 090000648048ed15
FDA-2002-D-0022-0002 FDA Medical Devices; Chemical Indicators Premarket Notification FDA-2002-D-0022 GUIDANCE Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T01:16:13Z   0 0 0900006480488e0f
FDA-2002-D-0022-0004 FDA Medical Devices; Chemical Indicators Premarket Notification FDA-2002-D-0022 FDA Notice NAD-Notice of Availability of Data 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-12-20T04:59:59Z 2008-04-12T01:16:13Z   0 0 0900006480488e14
FDA-2003-D-0244-0002 FDA Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision FDA-2003-D-0244 Guidance Supporting & Related Material GDL-Guidance 2003-12-30T05:00:00Z 2003 12     2008-04-12T00:55:07Z   0 0 090000648048ecfe
FDA-2000-N-0139-0002 FDA Changes to an Approved NDA or ANDA; Agency Information Collection FDA-2000-N-0139 Agency Information Collection Activities; Comment Request; Guidance for Industry-Changes to an Approved New Drug Application or Abbreviated New Drug Application Notice General Notice 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-02-18T04:59:59Z 2025-06-12T20:08:33Z 03-31412 0 0 09000064804d0bb0
FDA-2003-D-0428-0001 FDA Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0428 FDA Notice NAD-Notice of Availability of Data 2003-12-30T05:00:00Z 2003 12 2003-12-19T05:00:00Z 2004-12-20T04:59:59Z 2008-04-12T00:55:43Z   0 0 09000064804a21c9
FDA-2003-N-0096-0002 FDA Revision of the Requirements for Spore-Forming Microorganisms FDA-2003-N-0096 Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule Notice Notice of Final Rule 2003-12-30T05:00:00Z 2003 12 2003-12-30T05:00:00Z 2004-03-16T04:59:59Z 2025-06-18T19:14:55Z 03-31918 0 0 09000064804838f1
FDA-1980-N-0049-0067 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:42:07Z   0 0 09000064805b99cb
FDA-1980-N-0049-0077 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 12: "Protecting our Kids: What is causing the current shortage in childhood vaccines? Testimony Before the Committee on Governmental Affairs, United States Senate," June 12, 2002," http://www. cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002. htm Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T18:58:35Z   0 0 09000064805b99d5
FDA-1980-N-0049-0065 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 18: http://www.fda.gov/ohrms//dockets/ac/02/transcripts/3842t1.pdf Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:53:55Z   0 0 09000064805b99c9
FDA-1980-N-0049-0068 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 16: http://www.fda. gov/ohrms/dockets/ac/01/transcripts/3805t2_01 .pdf Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:31:09Z   0 0 09000064805b99cc
FDA-1980-N-0049-0074 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 6: Anthrax Vaccine Adsorbed (BIOTHRAX) Package Insert (January 31, 2002) Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:51:25Z   0 0 09000064805b99d2
FDA-1980-N-0049-0079 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference List Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:09:59Z   0 0 09000064805b99d7
FDA-1980-N-0049-0080 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 14: Centers for Disease Control and Prevention,"Prevention of Plague: Recommendations of the Advisory Committee on Immunization Practices (ACIP)," Morbidity and Mortality Weekly Report, 45 (No. RR-14), 1996 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T18:49:26Z   0 0 09000064805b99d8
FDA-1980-N-0049-0070 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 10: "Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)," September 1998, http://www.fda.gov/cber/gdlns/vaers-1.pdf Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:17:27Z   0 0 09000064805b99ce
FDA-1980-N-0049-0084 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T19:30:18Z   0 0 09000064805b99dc
FDA-1980-N-0049-0063 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 11: "Estimated Vaccination Coverage with 3+DTP Among Children 19-35 Months of Age by Race/Ethnicity, and by State and Immunization Action Plan Area - U.S., National Immunization Survey, Q3/2000 - Q2/2001," http://www.cdc.gov/nip/coverage/NlS/00-01/tab19- 3dpt_race_iap. htm. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T19:21:05Z   0 0 09000064805b99c7
FDA-1980-N-0049-0076 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:40:29Z   0 0 09000064805b99d4
FDA-1980-N-0049-0083 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 3: Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. M. Pitt, C. A. Rossi, P. H. Gibbs, and A. M. Friedlander, "Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin," Vaccine, 19(23-24):3241-3247, 2001 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T18:23:42Z   0 0 09000064805b99db
FDA-1980-N-0049-0081 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:41:44Z   0 0 09000064805b99d9
FDA-1980-N-0049-0082 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 4: Ivins, B. E., P. F. Fellows, M. L. M. Pitt, J. E. Estep, S. L. Welkos, P. L.Worsham and A. M. Friedlander, "Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys," Salisbury Medical Bulletin 87(Suppl.):125-126, 1996 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T18:30:13Z   0 0 09000064805b99da
FDA-1980-N-0049-0073 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 7: Wright, G. G., Green, T. W, and Kanode, Jr., R. G., "Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-Precipitated Protective Antigen," Journal of Immunology, 73:387- 391, 1954 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:57:23Z   0 0 09000064805b99d1
FDA-1980-N-0049-0075 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 1: Brachman, P. S., H. Gold, S. Plotkin, F. R. Fekety, M. Werrin, and N. R. Ingraham, "Field Evaluation of a Human Anthrax Vaccine," American Journal of Public Health, 52:632-645, 1962. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T16:42:28Z   0 0 09000064805b99d3
FDA-1980-N-0049-0064 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 9: "Table of Reportable Events Following Vaccination," http://www.vaers.org/reportable.htm. Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T19:11:53Z   0 0 09000064805b99c8
FDA-1980-N-0049-0071 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 13: Colditz, et al., "Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Meta Analysis of the Published Literature," Journal of the American Medical Association, 271:698-702, 1994 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:09:06Z   0 0 09000064805b99cf
FDA-2003-P-0177-0001 FDA Warning Label for all Food Products Which Contain Gluten FDA-2003-P-0177 Acknowledgment Letter from FDA DMB to Stockbridge Family Medicine Other Acknowledgement Letter/Receipt 2003-12-29T05:00:00Z 2003 12     2024-10-11T15:15:33Z   0 0 0900006480489c44
FDA-1980-N-0049-0066 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Transcript in the matter of Vaccines and Related Biological Products Advisory Committee Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-20T16:17:24Z   0 0 09000064805b99ca
FDA-1980-N-0049-0069 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 15: http://Mrww.fda.gov/ohrms/dockets/ac/01/transcripts/3755t1.pdf Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:26:38Z   0 0 09000064805b99cd
FDA-1980-N-0049-0078 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 5: Ivins, B. E., M. L. M. Pitt, P. F. Fellows, J. W. Farchaus, B. E. Benner, D. M. Waag, S. F. Little, G. W. Anderson, P. H. Gibbs, and A. M. Friedlander, "Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques," Vaccine, 16(11-12):1141-1148,1998 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T18:42:51Z   0 0 09000064805b99d6
FDA-1980-N-0049-0072 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Reference 8: 61 FR 40153, August 1, 1996 Supporting & Related Material Background Material 2003-12-29T05:00:00Z 2003 12     2020-05-19T17:01:43Z   0 0 09000064805b99d0
FDA-2003-P-0409-0001 FDA Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth FDA-2003-P-0409 HFA-305 to Hogan & Hartson L.L.P. Other ACK-Acknowledgement Letter 2003-12-24T05:00:00Z 2003 12     2008-04-12T01:13:30Z   0 0 09000064804a1b19
FDA-1994-P-0041-0231 FDA Require Labeling of Trans Fatty Acid & Prohibit Deceptive Claims-CLOSED FDA-1994-P-0041 HFC-1 to CSPI Other PAV-Petition Approval 2003-12-24T05:00:00Z 2003 12     2008-05-16T23:19:32Z   0 0 09000064804ff056
FDA-2002-P-0082-0001 FDA ANDA Sutability for Albuterol Base Inhalation Solution-CLOSED FDA-2002-P-0082 Petition Denial from FDA CDER to SensorMedics Corporation Other PDN-Petition Denial 2003-12-23T05:00:00Z 2003 12     2024-08-27T13:59:44Z   0 0 090000648048d94e
FDA-2003-P-0126-0002 FDA Requesting the Agency to Permit the Fling of an ANDA for A Drug Product (1.5 mg Levonorgestrel Tablet) Which is Not Indentical to the Reference Listed Drug (Plan B 0.75 mg Levonorgestrel Tablet) In Strength-CLOSED FDA-2003-P-0126 Petition Denial from FDA CDER to HRA Pharma Other PDN-Petition Denial 2003-12-23T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2024-10-17T21:12:42Z   0 0 09000064804861cf
FDA-2003-N-0161-0046 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:07Z   0 0 090000648048819d
FDA-2003-N-0161-0037 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:01Z   0 0 0900006480488178
FDA-2003-N-0161-0053 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:04Z   0 0 09000064804881b4
FDA-2003-N-0161-0041 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:07Z   0 0 0900006480488186
FDA-2003-N-0161-0040 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:07Z   0 0 0900006480488183
FDA-2003-P-0077-0004 FDA ANDA Suitability Petition for Clarithromycin Extended-Release Tablets-CLOSED FDA-2003-P-0077 HFD-600 to The Weinberg Group Inc Other PAV-Petition Approval 2003-12-23T05:00:00Z 2003 12     2008-04-12T01:10:53Z   0 0 09000064804829c8
FDA-2003-N-0161-0052 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:08Z   0 0 09000064804881b1
FDA-2003-N-0161-0035 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:01Z   0 0 090000648048816c
FDA-2003-N-0161-0048 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:00Z   0 0 09000064804881a4
FDA-2003-N-0161-0038 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:06Z   0 0 090000648048817d
FDA-2003-N-0161-0031 FDA Obesity and Nutrition FDA-2003-N-0161 FDA and the Office of Assistant Secretary of Planning and Evaluation - "Exploring the Link Between Weight Management and Food Labels and Packaging, November 20, 2003" - Supplement Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2009-11-21T23:28:52Z   0 0 0900006480488156
FDA-2003-N-0161-0034 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:58:59Z   0 0 0900006480488168
FDA-2003-N-0161-0030 FDA Obesity and Nutrition FDA-2003-N-0161 Shipping Label - [Bureau of Consumer Protection, Bureau of Economics, and the Office of Policy Planning, FTC - Comment] re FDA-2003-N-0161-0029 Supporting & Related Material C-Comment (Supporting and Related Material) 2003-12-23T05:00:00Z 2003 12     2012-03-24T19:28:36Z   0 0 0900006480488152
FDA-2003-N-0161-0036 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:02Z   0 0 0900006480488170
FDA-2003-N-0161-0050 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:00Z   0 0 09000064804881ab
FDA-2003-N-0161-0043 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:08Z   0 0 0900006480488191
FDA-2003-N-0161-0047 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:58:59Z   0 0 09000064804881a1
FDA-2003-N-0161-0049 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:01Z   0 0 09000064804881a8
FDA-2003-N-0161-0042 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:01Z   0 0 0900006480488189
FDA-2003-N-0161-0039 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:07Z   0 0 0900006480488180
FDA-2003-P-0116-0005 FDA Reclassify Cyclosporine (CSA) as Non-antibiotic Drug-CLOSED FDA-2003-P-0116 HF-22 to Fish & Richardson, PC and Arnold & Porter Other PDN-Petition Denial 2003-12-23T05:00:00Z 2003 12     2008-04-12T01:10:57Z   0 0 090000648048540d
FDA-2003-P-0013-0001 FDA ANDA suitability for carbamazepine tablets, 100mg, 300mg,400-CLOSED FDA-2003-P-0013 Petition Approval Letter from FDA CDER to Taro Pharmaceuticals, U.S.A., Inc. Other PAV-Petition Approval 2003-12-23T05:00:00Z 2003 12 2003-12-22T05:00:00Z   2024-10-07T20:33:42Z   0 0 090000648048129e
FDA-2003-N-0161-0044 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:01Z   0 0 0900006480488195
FDA-2003-N-0161-0051 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:08Z   0 0 09000064804881ae
FDA-2003-N-0161-0045 FDA Obesity and Nutrition FDA-2003-N-0161 Exploring the Link Between Food Labeling and Weight Management Other SUP-Supplement 2003-12-23T05:00:00Z 2003 12     2008-04-12T00:59:08Z   0 0 0900006480488199
FDA-2003-N-0161-0033 FDA Obesity and Nutrition FDA-2003-N-0161 Attachment 2 - "Written in a Foriegn Language" - [FDA and the Office of Assistant Secretary of Planning and Evaluation - "Exploring the Link Between Weight Management and Food Labels and Packaging, November 20, 2003" - Supplement] Supporting & Related Material   2003-12-23T00:00:00Z 2003 12     2009-11-21T23:37:52Z   0 1 0900006480488160
FDA-2003-N-0161-0032 FDA Obesity and Nutrition FDA-2003-N-0161 Attachment 1 - "Written in a Foriegn Language" - [FDA and the Office of Assistant Secretary of Planning and Evaluation - "Exploring the Link Between Weight Management and Food Labels and Packaging, November 20, 2003" - Supplement] Supporting & Related Material   2003-12-23T00:00:00Z 2003 12     2009-11-21T23:33:57Z   0 1 090000648048815a
FDA-2003-Q-0080-0003 FDA Qualified Health Claim: Monounsaturated Fatty Acids & Reduced Risk of Coronary Heart Disease FDA-2003-Q-0080 FDA/CFSAN to Nutrition Solutions Other LET-Letter 2003-12-19T05:00:00Z 2003 12     2009-03-10T16:13:57Z   0 0 0900006480482da7
FDA-2003-V-0360-0001 FDA Laser Light Show FDA-2003-V-0360 HFA-305 to True Lasers LLC. Other ACK-Acknowledgement Letter 2003-12-19T05:00:00Z 2003 12     2008-04-12T01:14:58Z   0 0 0900006480497c4a
FDA-2003-Q-0080-0002 FDA Qualified Health Claim: Monounsaturated Fatty Acids & Reduced Risk of Coronary Heart Disease FDA-2003-Q-0080 Acknowledgement Letter [FDA/CFSAN] to North American Olive Oil Association Other ACK-Acknowledgement Letter 2003-12-19T05:00:00Z 2003 12     2009-04-17T20:45:09Z   0 0 0900006480482da6
FDA-2003-Q-0080-0001 FDA Qualified Health Claim: Monounsaturated Fatty Acids & Reduced Risk of Coronary Heart Disease FDA-2003-Q-0080 FDA/CFSAN - Memorandum of Telephone Conversation Other MT-Memorandum of Telephone Conversation 2003-12-19T05:00:00Z 2003 12     2009-04-17T20:44:22Z   0 0 0900006480482cfa
FDA-2003-P-0116-0004 FDA Reclassify Cyclosporine (CSA) as Non-antibiotic Drug-CLOSED FDA-2003-P-0116 HFD-5 to Fish & Richardson and Arnold & Porter Other LET-Letter 2003-12-18T05:00:00Z 2003 12     2008-04-12T01:10:58Z   0 0 090000648048540a
FDA-2003-P-0007-0003 FDA determine whether Lexapro (escitalopram oxalate) tablets 5 mg (NDA 21-323, Product 001),manufactured by Forest laboratories, have been withdrawn or withheld from sale for safety or efficacy reasons FDA-2003-P-0007 Letter from FDA CDER to Lachman Consultant Services, Inc. Other LET-Letter 2003-12-18T05:00:00Z 2003 12 2003-12-16T05:00:00Z   2024-10-28T21:19:37Z   0 0 09000064804811b6
FDA-2002-D-0023-0004 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 FDA Notice NAD-Notice of Availability of Data 2003-12-18T05:00:00Z 2003 12 2003-12-17T05:00:00Z 2004-12-19T04:59:59Z 2008-04-12T01:16:14Z   0 0 0900006480488ef4
FDA-2002-D-0023-0002 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 Guidance Supporting & Related Material GDL-Guidance 2003-12-18T05:00:00Z 2003 12     2008-04-12T01:16:14Z   0 0 0900006480488ef0
FDA-2002-D-0023-0005 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 FDA Notice NAD-Notice of Availability of Data 2003-12-18T05:00:00Z 2003 12 2003-12-17T05:00:00Z 2004-12-19T04:59:59Z 2008-04-12T01:16:14Z   0 0 0900006480488ef6
FDA-2002-D-0023-0003 FDA Human Dura Mater; Class II Special Controls Guidance FDA-2002-D-0023 Guidance Supporting & Related Material GDL-Guidance 2003-12-18T05:00:00Z 2003 12     2008-04-12T01:16:14Z   0 0 0900006480488ef2
FDA-2003-V-0236-0002 FDA Laser Light Show FDA-2003-V-0236 HFZ-300 to Carnaval Night Club Other VRA-Approval for Variance 2003-12-18T05:00:00Z 2003 12     2008-04-12T01:14:33Z   0 0 090000648048e2d4
FDA-2002-N-0064-0003 FDA Neurological Devices; Classification of Human Dura Mater FDA-2002-N-0064 Neurological Devices; Classification of Human Dura Mater Notice Notice of Final Rule 2003-12-18T00:00:00Z 2003 12 2003-12-18T05:00:00Z   2025-05-13T07:52:58Z 03-31174 0 0 090000648048c4de
FDA-2003-D-0186-0003 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 Guidance Supporting & Related Material GDL-Guidance 2003-12-17T05:00:00Z 2003 12     2008-04-12T00:54:52Z   0 0 090000648048a86d
FDA-2002-N-0233-0084 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 HF-1 Other M-Memorandum 2003-12-17T05:00:00Z 2003 12     2008-04-12T01:23:44Z   0 0 090000648049880b
FDA-2003-D-0186-0005 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 FDA Notice NAD-Notice of Availability of Data 2003-12-17T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2008-04-12T00:54:52Z   0 0 090000648048a872
FDA-2002-N-0064-0002 FDA Neurological Devices; Classification of Human Dura Mater FDA-2002-N-0064 Neurological Devices; Classification of Human Dura Mater Notice Notice of Final Rule 2003-12-17T05:00:00Z 2003 12 2003-12-18T05:00:00Z   2025-05-13T07:51:26Z 03-31174 0 0 090000648048c4db
FDA-2003-D-0186-0002 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 Guidance Supporting & Related Material GDL-Guidance 2003-12-17T05:00:00Z 2003 12     2008-04-12T00:54:51Z   0 0 090000648048a86b
FDA-1980-P-0014-0001 FDA EXEMPT CERIUM (R) FROM GMP (CONFIDENTIAL)-CLOSED FDA-1980-P-0014 memo Other M-Memorandum 2003-12-17T05:00:00Z 2003 12     2008-05-30T22:52:54Z   0 0 09000064805b9288
FDA-2003-D-0186-0004 FDA Food and Cosmetic Security Guidances FDA-2003-D-0186 FDA Notice NAD-Notice of Availability of Data 2003-12-17T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2008-04-12T00:54:52Z   0 0 090000648048a86f
FDA-2000-N-0224-0004 FDA Human Prescripton Drugs/Biologics in Electronic Format - CLOSED FDA-2000-N-0224 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Notice of Approval Notice Notice of Approval 2003-12-16T05:00:00Z 2003 12 2003-12-16T05:00:00Z   2015-12-09T14:52:39Z   0 0 09000064804d542a
FDA-2002-N-0233-0082 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 Guidance Supporting & Related Material GDL-Guidance 2003-12-16T05:00:00Z 2003 12     2008-04-12T01:23:28Z   0 0 0900006480498806
FDA-2003-P-0173-0002 FDA Health Center, be deemed a ' pharmacy of an other health care entity'-CLOSED FDA-2003-P-0173 Petition Approval from FDA Associate Commissioner for Regulatory Affairs to Family Care Health Centers Other PAV-Petition Approval 2003-12-16T05:00:00Z 2003 12 2003-12-10T05:00:00Z   2024-10-28T21:52:51Z   0 0 0900006480489305
FDA-2003-N-0383-0001 FDA Premarket Notification Submission 510(K), FDA-2003-N-0383 Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification Submissions Notice 60 Day Proposed Information Collection 2003-12-16T05:00:00Z 2003 12 2003-12-16T05:00:00Z 2004-02-18T04:59:59Z 2025-06-23T18:52:24Z 03-30964 0 0 090000648049a1f9
FDA-2003-V-0423-0001 FDA Laser Light Show FDA-2003-V-0423 HFA-305 to Rowan University, Department of Physics & Astronomy Other ACK-Acknowledgement Letter 2003-12-16T05:00:00Z 2003 12     2008-04-12T01:15:09Z   0 0 09000064804a1d79
FDA-2003-P-0346-0001 FDA 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies FDA-2003-P-0346 Acknowledgement Letter from FDA DMB to Beckman Coulter, Inc. Other Acknowledgement Letter/Receipt 2003-12-16T05:00:00Z 2003 12 2003-12-16T05:00:00Z   2024-11-25T16:27:06Z   0 0 0900006480496db0
FDA-2000-N-0224-0003 FDA Human Prescripton Drugs/Biologics in Electronic Format - CLOSED FDA-2000-N-0224 Supporting Statement re: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format - Agency Information Collection Activities Supporting & Related Material Background Material 2003-12-16T05:00:00Z 2003 12     2015-12-09T14:45:25Z   0 0 09000064804d5429
FDA-2002-N-0233-0083 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 FDA Notice NAD-Notice of Availability of Data 2003-12-16T05:00:00Z 2003 12 2003-12-12T05:00:00Z 2004-12-17T04:59:59Z 2008-04-12T01:23:40Z   0 0 0900006480498809
FDA-2003-N-0157-0004 FDA Submitting & Reviewing Complete Responses for Clinical Holds FDA-2003-N-0157 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds Notice Notice of Approval 2003-12-16T05:00:00Z 2003 12     2025-02-27T17:09:04Z 03-30963 0 0 0900006480487917
FDA-2003-N-0157-0003 FDA Submitting & Reviewing Complete Responses for Clinical Holds FDA-2003-N-0157 Supporting Statement - Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds Supporting & Related Material Background Material 2003-12-16T05:00:00Z 2003 12     2025-02-27T17:27:11Z   0 0 0900006480487915
FDA-2003-D-0435-0001 FDA Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0435 Compliance Policy Guide Sec. 110.3 10 - “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability Notice NAD-Notice of Availability of Data 2003-12-15T05:00:00Z 2003 12 2003-12-15T05:00:00Z   2009-03-10T21:04:02Z   0 0 09000064804a234b
FDA-2003-N-0196-0020 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Response from FDA/CDER to Buchanan Ingersoll Other Answer 2003-12-15T05:00:00Z 2003 12     2014-06-09T21:16:55Z   0 0 090000648048b603
FDA-2002-N-0233-0081 FDA Bioterrorism; Prior Notice of Imported Food Shipments FDA-2002-N-0233 FDA Notice NAD-Notice of Availability of Data 2003-12-15T05:00:00Z 2003 12 2003-12-12T05:00:00Z   2008-04-12T01:23:22Z   0 0 0900006480498804
FDA-2003-D-0435-0003 FDA Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0435 Guidance for FDA and CBP Staff Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - Guidance Other GDL-Guidance (Supporting and Related Materials) 2003-12-15T05:00:00Z 2003 12     2009-03-10T21:06:01Z   0 0 09000064804a2352
FDA-2003-N-0196-0021 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Response from FDA/CDER to North America Cosmetic Division, Symrise Other Answer 2003-12-15T05:00:00Z 2003 12     2014-06-09T21:22:06Z   0 0 090000648048b618

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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);