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withdrawn,object_id FDA-2003-D-0428-0003,FDA,FDA-2003-D-0428,GUIDANCE,Supporting & Related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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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