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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

424 rows where agency_id = "FDA" and posted_year = 2001 sorted by posted_date descending

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posted_year 1

  • 2001 · 424 ✖

agency_id 1

  • FDA · 424 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2001-N-0018-0001 FDA Preparation for ICH Meetings in Brussels, Belgium FDA-2001-N-0018 Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementation of the Common Technical Document; Notice of Public Meeting Notice General Notice 2001-12-31T05:00:00Z 2001 12     2025-02-10T16:52:56Z 01-32123 0 0 09000064804b5107
FDA-1978-N-0018-0441 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Final Rule Notice Notice of Stay of Action 2001-12-31T05:00:00Z 2001 12 2001-12-31T05:00:00Z 2002-04-02T04:59:59Z 2019-07-25T19:32:43Z 01-32086 0 0 090000648055a801
FDA-1993-D-0022-0001 FDA Microbiological Testing Antimicrobial Drug Residues in Foods FDA-1993-D-0022 FDA Notice NAD-Notice of Availability of Data 2001-12-31T05:00:00Z 2001 12 2001-12-27T05:00:00Z   2008-05-16T23:23:01Z   0 0 09000064804face9
FDA-2001-N-0015-0001 FDA Agency Information Collection; Customer/Partner Ser Surveys FDA-2001-N-0015 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Customer/Partner Service Surveys Notice 30 Day Proposed Information Collection 2001-12-31T05:00:00Z 2001 12 2001-12-20T05:00:00Z 2002-01-23T04:59:59Z 2025-01-17T16:28:25Z 01-31335 0 0 09000064804b4d73
FDA-2001-D-0223-0001 FDA Guidance on Labeling of Reprocessed Single Use Devices FDA-2001-D-0223 FDA Notice N-Notice 2001-12-28T05:00:00Z 2001 12 2001-12-28T05:00:00Z 2002-03-21T04:59:59Z 2008-04-25T02:28:02Z   0 0 09000064804e5374
FDA-2001-P-0155-0001 FDA Requirement of ANDA for Mixed Salts of Single Entity Amphetamine-CLOSED FDA-2001-P-0155 FDA/DDM to Arnall, Golden Gregory Other ACK-Acknowledgement Letter 2001-12-27T05:00:00Z 2001 12     2008-04-25T02:27:48Z   0 0 09000064804df043
FDA-2001-P-0053-0001 FDA New and/or Amended Regulations for BPCA-CLOSED FDA-2001-P-0053 Acknowledgment Letter from FDA DMB to Wilmer, Cutler & Pickering Other Acknowledgement Letter/Receipt 2001-12-27T05:00:00Z 2001 12     2024-09-23T22:37:14Z   0 0 09000064804b7e38
FDA-2000-D-1403-0001 FDA Potassium Iodide as a Thyroid Blocking Agent FDA-2000-D-1403 Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies Notice Guidance 2001-12-21T05:00:00Z 2001 12 2021-10-01T04:00:00Z 2002-12-12T04:59:59Z 2024-11-07T21:53:19Z   1 0 09000064804f0f7f
FDA-2001-N-0172-0002 FDA Prescription Drug Product Labeling; Medication Guide Require FDA-2001-N-0172 FDA Notice N-Notice 2001-12-17T05:00:00Z 2001 12 2001-12-17T05:00:00Z 2002-01-15T04:59:59Z 2008-04-25T02:27:22Z   0 0 09000064804e0ae7
FDA-2001-P-0452-0001 FDA ANDA Suitability for a Change in Dosage Form for Imuren-CLOSED FDA-2001-P-0452 Approval Letter from FDA CDER to AA1 International Other Approval 2001-12-17T05:00:00Z 2001 12 2021-01-28T05:00:00Z   2021-02-01T17:19:08Z   0 0 0900006484a0af87
FDA-2001-P-0191-0001 FDA Refrain Approval of Any Buprenorphine Product-CLOSED FDA-2001-P-0191 FDA/DDM to Hogan & Hartson, LLP Other ACK-Acknowledgement Letter 2001-12-11T05:00:00Z 2001 12     2008-04-25T02:25:58Z   0 0 09000064804e2665
FDA-2001-P-0215-0002 FDA Determine whether Sotradecol has been withdrawn from sale in FDA-2001-P-0215 Acknowledgment Letter from FDA DMB to Omega Laboratories, Ltd. Other ACK-Acknowledgement Letter 2001-12-07T05:00:00Z 2001 12     2024-08-23T13:49:30Z   0 0 09000064804e488d
FDA-2001-N-0230-0002 FDA Prescription Drug User Fee Act (PDUFA) FDA-2001-N-0230 FDA Notice NCR-Notice of Correction 2001-12-07T05:00:00Z 2001 12     2008-04-25T02:38:50Z   0 0 09000064804e5d77
FDA-2001-D-0040-0001 FDA Food-Effect Bioavailability & Fed Bioequivalence Studies FDA-2001-D-0040 FDA Notice NAD-Notice of Availability of Data 2001-11-29T05:00:00Z 2001 11 2001-11-29T05:00:00Z 2002-01-29T04:59:59Z 2008-04-25T01:57:07Z   0 0 09000064804b6d71
FDA-2001-P-0086-0002 FDA Dissemination of Non-Misleading Information/Off-Label Uses-CLOSED FDA-2001-P-0086 FDA/OC to Washington Legal Foundation Other LET-Letter 2001-11-27T05:00:00Z 2001 11     2008-04-25T02:23:19Z   0 0 09000064804b8543
FDA-2001-N-0070-0002 FDA Agency Information Collection Recall Regulations FDA-2001-N-0070 Agency Information Collection Activities; Submission for OMB Review; Comment Request; FDA Recall Regulations Notice 30 Day Proposed Information Collection 2001-11-27T05:00:00Z 2001 11 2001-08-17T04:00:00Z 2001-09-18T03:59:59Z 2024-12-09T19:21:59Z 01-20842 0 0 09000064804b825f
FDA-2001-D-0032-0004 FDA Clinical Studies Section for Prescription Drugs & Biologics FDA-2001-D-0032 FDA Notice NEC-Notice of Extension 2001-11-21T05:00:00Z 2001 11 2001-11-21T05:00:00Z 2001-11-27T04:59:59Z 2008-04-25T01:57:06Z   0 0 09000064804b6347
FDA-2001-D-0219-0002 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability Notice NAD-Notice of Availability of Data 2001-11-20T05:00:00Z 2001 11 2001-11-19T05:00:00Z 2002-02-20T04:59:59Z 2010-05-10T16:34:55Z   0 0 09000064804e4e02
FDA-1999-D-1301-0001 FDA Information Request & Discipline Review Letter FDA-1999-D-1301 Guidance for Industry: Information Request & Discipline Review Letters Under the Prescription Drug User Fee Act Notice Guidance 2001-11-20T05:00:00Z 2001 11 2001-11-20T05:00:00Z   2025-06-17T21:52:51Z   1 0 09000064804da900
FDA-2001-N-0230-0001 FDA Prescription Drug User Fee Act (PDUFA) FDA-2001-N-0230 FDA Notice NM-Notice of Meeting 2001-11-19T05:00:00Z 2001 11 2001-11-19T05:00:00Z 2002-01-26T04:59:59Z 2008-04-25T02:38:50Z   0 0 09000064804e5c39
FDA-1978-N-0018-0440 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Memorandum of Meeting Between FDA/OCC and Cosmetic, Toiletry and Fragrance Association Other Memorandum 2001-11-19T05:00:00Z 2001 11     2019-08-07T12:11:46Z   0 0 090000648055a7fe
FDA-1999-N-0053-0004 FDA Medical Devices; Reclassification of 38 Preamendments FDA-1999-N-0053 FDA Notice NFR-Notice of Final Rule 2001-11-16T05:00:00Z 2001 11     2008-04-25T00:00:45Z   0 0 09000064804a6196
FDA-1999-N-0083-0001 FDA Assessment of Preclinical Reproductive Toxicity Data FDA-1999-N-0083 FDA Notice NAD-Notice of Availability of Data 2001-11-15T05:00:00Z 2001 11 2001-11-15T05:00:00Z 2002-03-14T04:59:59Z 2008-04-25T00:00:59Z   0 0 09000064804a6982
FDA-2000-D-0196-0001 FDA Fumonisin Levels in Human Foods and Animal Feed FDA-2000-D-0196 Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Availability Notice Notice of Availability 2001-11-14T05:00:00Z 2001 11 2001-11-09T05:00:00Z 2002-11-10T04:59:59Z 2018-10-10T18:41:38Z   0 0 09000064804d4563
FDA-1980-N-0074-0075 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 FDA/ORA to Colgate-Palmolive Company Other PDN-Petition Denial 2001-11-14T05:00:00Z 2001 11     2008-05-30T22:52:47Z   0 0 09000064805bb4db
FDA-2001-D-0137-0002 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb03
FDA-2001-D-0137-0007 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb0b
FDA-2001-N-0176-0001 FDA Inhalational Anthrax (Post-Exposure) Doxycycline/PenicillinG FDA-2001-N-0176 FDA Notice N-Notice 2001-11-06T05:00:00Z 2001 11     2008-04-25T02:27:33Z   0 0 09000064804e1102
FDA-2001-N-0176-0002 FDA Inhalational Anthrax (Post-Exposure) Doxycycline/PenicillinG FDA-2001-N-0176 FDA Notice N-Notice 2001-11-06T05:00:00Z 2001 11     2008-04-25T02:27:34Z   0 0 09000064804e133a
FDA-2001-D-0137-0001 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddaef
FDA-2001-N-0074-0002 FDA Withdrawal of 51 NDAs and 25 ANDAs FDA-2001-N-0074 Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 Abbreviated New Drug Applications; Correction Notice Correction 2001-11-06T05:00:00Z 2001 11     2025-01-29T14:22:16Z 01-27520 0 0 09000064804b831d
FDA-2001-D-0137-0006 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb0a
FDA-2001-D-0137-0009 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb0d
FDA-2001-D-0137-0008 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb0c
FDA-2001-N-0074-0003 FDA Withdrawal of 51 NDAs and 25 ANDAs FDA-2001-N-0074 Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 Abbreviated New Drug Applications; Correction Notice Correction 2001-11-06T05:00:00Z 2001 11     2025-01-29T14:37:32Z 01-27520 0 0 09000064804b831e
FDA-2001-D-0137-0003 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb05
FDA-2001-D-0137-0005 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb09
FDA-2001-D-0137-0004 FDA Evalution of the effects of Orally Inhaled and Intranasal FDA-2001-D-0137 FDA Notice NAD-Notice of Availability of Data 2001-11-06T05:00:00Z 2001 11 2001-11-06T05:00:00Z 2002-02-05T04:59:59Z 2008-04-25T02:25:55Z   0 0 09000064804ddb08
FDA-2001-D-0219-0001 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Draft FDA Guidance on the Estabtishment and Operation of Clinical Trial Data Monitoring Committees; Public Meeting Notice NM-Notice of Meeting 2001-11-05T05:00:00Z 2001 11     2010-05-10T16:33:19Z   0 0 09000064804e4d7b
FDA-2001-N-0016-0001 FDA Veterinary adverse drug reaction, lack of effect, product FDA-2001-N-0016 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report Notice 30 Day Proposed Information Collection 2001-11-05T05:00:00Z 2001 11 2001-11-05T05:00:00Z 2001-12-06T04:59:59Z 2024-12-17T02:00:53Z 01-27641 0 0 09000064804b4ea8
FDA-2001-N-0171-0001 FDA Medical Devices: Third-Party review under FDAMA;Agency Infor FDA-2001-N-0171 Agency Information Collection Activities; Announcement of OMB Approval; Third-Party Review Under FDAMA Notice Notice of Approval 2001-11-05T05:00:00Z 2001 11     2024-12-16T17:04:30Z 01-27642 0 0 09000064804e0921
FDA-2000-D-0027-0001 FDA Patulin in Apple Juice,Apple Juice Concentrates,Juice Produc FDA-2000-D-0027 FDA Notice NAD-Notice of Availability of Data 2001-11-05T05:00:00Z 2001 11     2008-04-25T01:01:00Z   0 0 09000064804aeaf2
FDA-2018-D-4115-0013 FDA FDA-2018-D-4115 The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final Guidance for Industry and FDA Other Guidance 2001-11-04T05:00:00Z 2001 11 2001-11-04T05:00:00Z   2024-11-06T23:36:50Z   1 0 0900006484644a3f
FDA-2001-P-0239-0005 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Letter from FDA CFSAN to Krislov & Associates, LTD. Other Letter(s) 2001-10-31T05:00:00Z 2001 10 2020-07-06T04:00:00Z   2024-09-09T17:22:16Z   0 0 09000064804e6814
FDA-2001-P-0239-0004 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Letter from FDA CFSAN to Center for Food Safety Other Letter(s) 2001-10-31T05:00:00Z 2001 10 2020-07-06T04:00:00Z   2024-09-09T17:22:06Z   0 0 09000064804e6812
FDA-1998-N-0050-0002 FDA Comprehensive List of Current Guidance Documents at FDA FDA-1998-N-0050 Annual Comprehensive List of Guidance Documents at the Food and Drug Administration Notice General Notice 2001-10-29T05:00:00Z 2001 10 2001-10-24T04:00:00Z   2015-04-11T02:07:31Z   0 0 090000648056e813
FDA-2001-N-0174-0001 FDA Electronic Interchange Standard for Digital ECG; Public Meet FDA-2001-N-0174 Electronic Interchange Standard for Digital ECG and Similar Data; Public Meeting Notice Meeting 2001-10-29T05:00:00Z 2001 10     2025-02-06T02:00:57Z 01-26821 0 0 09000064804e0d65
FDA-2001-N-0201-0001 FDA Food Labeling; Notification Procedures on Dietary Supplement FDA-2001-N-0201 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements Notice 60 Day Proposed Information Collection 2001-10-29T05:00:00Z 2001 10     2025-02-04T17:06:58Z 01-26885 0 0 09000064804e35f6
FDA-1999-F-0120-0003 FDA Listed Gum or Wood Rosin Derivatives FDA-1999-F-0120 Food Additives Permitted for Direct Addition to Food for Human Consumption; Change in Specifications for Gum or Wood Rosin Derivatives in Chewing Gum Base; Correction Notice Correction 2001-10-29T00:00:00Z 2001 10     2025-05-02T18:20:56Z 01-26708 0 0 09000064804ae961
FDA-2001-N-0199-0001 FDA Premarket Notification 510(k) Submissions FDA-2001-N-0199 Agency Information Collection Activities; Announcement of OMB Approval; Premarket Notification 510(k) Submissions Notice Notice of Approval 2001-10-26T04:00:00Z 2001 10     2024-12-10T16:05:25Z 01-26573 0 0 09000064804e3357
FDA-2001-D-0094-0002 FDA Channels of trade policy for Commodities with Vinclozolin FDA-2001-D-0094 FDA Notice N-Notice 2001-10-23T04:00:00Z 2001 10 2001-10-23T04:00:00Z 2001-11-24T04:59:59Z 2008-04-25T02:23:58Z   0 0 09000064804b90d5
FDA-2001-N-0104-0001 FDA Fast Track Drug Development Programs: Designation, Development, and Application Review FDA-2001-N-0104 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review Notice 60 Day Proposed Information Collection 2001-10-23T04:00:00Z 2001 10 2001-10-23T04:00:00Z 2001-12-25T04:59:59Z 2025-02-03T20:03:20Z 01-26575 0 0 09000064804bae60
FDA-1980-N-0074-0074 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 FDA Notice N-Notice 2001-10-22T04:00:00Z 2001 10 2001-10-22T04:00:00Z 2002-01-15T04:59:59Z 2008-05-30T22:53:09Z   0 0 09000064805bb4da
FDA-2001-N-0170-0001 FDA Medical Device Labeling Regulations FDA-2001-N-0170 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Device Labeling Regulations Notice 30 Day Proposed Information Collection 2001-10-19T04:00:00Z 2001 10 2001-10-16T04:00:00Z 2001-11-16T04:59:59Z 2024-12-19T19:57:40Z 01-25943 0 0 09000064804e07d0
FDA-2001-N-0566-0001 FDA New Animal Drugs for Investigational;Agency Information Coll FDA-2001-N-0566 Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use Notice 60 Day Proposed Information Collection 2001-10-19T04:00:00Z 2001 10 2001-10-16T04:00:00Z 2001-12-18T04:59:59Z 2025-02-03T18:49:59Z 01-25918 0 0 090000648050b0cb
FDA-1998-D-0037-0001 FDA Format for Geriatric Labeling FDA-1998-D-0037 FDA Notice NAD-Notice of Availability of Data 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2002-10-06T03:59:59Z 2008-05-16T21:18:13Z   0 0 0900006480565bc6
FDA-2000-D-0100-0002 FDA Clinical Data In Marketing Applications FDA-2000-D-0100 FDA Notice NAD-Notice of Availability of Data 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2002-10-06T03:59:59Z 2008-04-25T01:47:25Z   0 0 09000064804c217b
FDA-2000-P-0102-0004 FDA Health Claim: Vegetable Oil Sterol Esters & Coronary Heart Disease CLOSED 05/26/2020 FDA-2000-P-0102 FDA Notice NEC-Notice of Extension 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2001-11-20T04:59:59Z 2008-04-25T01:47:38Z   0 0 09000064804c22da
FDA-2000-P-0133-0004 FDA Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020 FDA-2000-P-0133 FDA Notice NEC-Notice of Extension 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2001-11-20T04:59:59Z 2008-04-25T01:16:05Z   0 0 09000064804cfd51
FDA-1998-D-0037-0002 FDA Format for Geriatric Labeling FDA-1998-D-0037 FDA Notice NAD-Notice of Availability of Data 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2002-10-06T03:59:59Z 2008-05-16T21:18:13Z   0 0 0900006480565c35
FDA-2001-N-0068-0001 FDA GLP Regulations for Nonclinical Laboratory Studies FDA-2001-N-0068 Agency Information Collection Activities; Announcement of OMB Approval; Good Laboratory Practices (GLP) Regulations for Nonclinical Laboratory Studies Notice Notice of Approval 2001-10-12T04:00:00Z 2001 10     2025-02-11T16:56:25Z 01-25659 0 0 09000064804b81dc
FDA-2001-N-0226-0002 FDA Reports of Corrections and Removals:Agency Information Colle FDA-2001-N-0226 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reports of Corrections and Removals Notice 30 Day Proposed Information Collection 2001-10-12T04:00:00Z 2001 10 2001-10-12T04:00:00Z 2001-11-14T04:59:59Z 2025-01-15T20:59:09Z 01-25660 0 0 09000064804e57a8
FDA-2001-N-0072-0001 FDA CGMP Regulations for Type A Medicated Articles FDA-2001-N-0072 Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Type A Medicated Articles Notice Notice of Approval 2001-10-12T04:00:00Z 2001 10     2024-11-26T02:00:30Z 01-25658 0 0 09000064804b82d8
FDA-2001-N-0105-0001 FDA Third-Party Submissions review/quality system inspections FDA-2001-N-0105 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under United States/European Community Mutual Recognition Agreement Notice 60 Day Proposed Information Collection 2001-10-12T04:00:00Z 2001 10 2001-10-05T04:00:00Z 2001-12-05T04:59:59Z 2025-01-31T16:15:35Z 01-24998 0 0 09000064804bafb0
FDA-2000-D-0068-0001 FDA Electronic Signatures: Glossary of Terms FDA-2000-D-0068 FDA Notice NCR-Notice of Correction 2001-10-11T04:00:00Z 2001 10     2008-04-25T01:13:24Z   0 0 09000064804afe17
FDA-2001-N-0202-0002 FDA Workshop on Preclinical Testing for Endovascular Grafts FDA-2001-N-0202 Workshop on Preclinical Testing for Endovascular Grafts Notice NM-Notice of Meeting 2001-10-10T04:00:00Z 2001 10     2009-01-07T16:52:55Z   0 0 09000064804e3787
FDA-2001-N-0202-0001 FDA Workshop on Preclinical Testing for Endovascular Grafts FDA-2001-N-0202 Workshop on Preclinical Testing for Endovascular Grafts Notice NM-Notice of Meeting 2001-10-10T04:00:00Z 2001 10     2009-01-07T16:51:36Z 01–16471 0 0 09000064804e373f
FDA-2001-N-0567-0001 FDA Substances Prohibited from use in animal food/Feed Ruminant FDA-2001-N-0567 FDA Notice NH-Notice of Hearing 2001-10-10T04:00:00Z 2001 10     2008-04-25T02:39:30Z   0 0 090000648050b0de
FDA-1999-P-0059-0004 FDA Reg/Guide to Label Medical Devices contain'g Phthalate Plasticizers-CLOSED FDA-1999-P-0059 FDA/DMB to Health Care Without Harm Other ACK-Acknowledgement Letter 2001-10-05T04:00:00Z 2001 10     2008-04-25T00:13:56Z   0 0 09000064804a671c
FDA-2001-N-0047-0002 FDA Progress on implementing for the common technical document FDA-2001-N-0047 Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementing of the Common Technical Document; Public Meeting; Cancellation Notice General Notice 2001-10-02T04:00:00Z 2001 10     2025-01-30T19:01:03Z 01-24528 0 0 09000064804b78ae
FDA-1974-P-0001-0002 FDA Vinyl Chloride as ingredient Drug/Cosmetic Aerosol Products, OPEN FDA-1974-P-0001 Notice of Proposed Rule-Making re Vinyl Chloride as an Ingredient of Drug and Cosmetic Aerosol Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2001-10-02T04:00:00Z 2001 10     2023-11-03T12:16:00Z 74-19657 0 0 090000648046a741
FDA-2001-P-0005-0001 FDA Determination that Disulfiram was withdrawn for reasons othe FDA-2001-P-0005 Notice of Determination Notice N-Notice 2001-10-01T04:00:00Z 2001 10     2024-08-28T13:26:37Z   0 0 09000064804b4014
FDA-2001-N-0173-0001 FDA Rapid Response Surveys;Agency Information Collection FDA-2001-N-0173 Agency Information Collection Activities; Proposed Collection; Comment Request; Rapid Response Surveys Notice 60 Day Proposed Information Collection 2001-10-01T04:00:00Z 2001 10 2001-09-27T04:00:00Z 2001-11-27T04:59:59Z 2025-01-30T21:09:38Z 01-24163 0 0 09000064804e0bdd
FDA-1998-D-0037-0003 FDA Format for Geriatric Labeling FDA-1998-D-0037 Content and Format for Geriatric Labeling Notice Guidance 2001-10-01T04:00:00Z 2001 10 2001-10-01T04:00:00Z   2021-10-01T04:02:28Z   0 0 0900006480565c32
FDA-1974-P-0001-0001 FDA Vinyl Chloride as ingredient Drug/Cosmetic Aerosol Products, OPEN FDA-1974-P-0001 Notice of Proposed Rule-Making re: Vinyl Chloride as an Ingredient of Drug and Cosmetic Aerosol Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2001-10-01T04:00:00Z 2001 10 2001-10-01T04:00:00Z 1974-05-03T03:59:59Z 2023-11-03T12:14:27Z 74-9282 0 0 090000648046a6ff
FDA-2000-D-0002-0003 FDA Q7A ICH Good Manufacturing Practice Guide for Active Pharmaceuticals FDA-2000-D-0002 FDA Notice NAD-Notice of Availability of Data 2001-09-26T04:00:00Z 2001 9     2008-04-25T01:13:52Z   0 0 09000064804ae5c1
FDA-2001-D-0164-0002 FDA Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil FDA-2001-D-0164 Guidance Supporting & Related Material GDL-Guidance 2001-09-26T04:00:00Z 2001 9     2008-04-25T02:27:39Z   0 0 09000064804dff9e
FDA-2001-N-0172-0001 FDA Prescription Drug Product Labeling; Medication Guide Require FDA-2001-N-0172 FDA Notice N-Notice 2001-09-26T04:00:00Z 2001 9 2001-09-26T04:00:00Z 2001-11-27T04:59:59Z 2008-04-25T02:27:22Z   0 0 09000064804e0a96
FDA-2000-D-0002-0002 FDA Q7A ICH Good Manufacturing Practice Guide for Active Pharmaceuticals FDA-2000-D-0002 Guidance Supporting & Related Material GDL-Guidance 2001-09-26T04:00:00Z 2001 9     2008-04-25T01:13:52Z   0 0 09000064804ae5c0
FDA-2001-D-0164-0001 FDA Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil FDA-2001-D-0164 FDA Notice NAD-Notice of Availability of Data 2001-09-26T04:00:00Z 2001 9 2001-09-26T04:00:00Z 2001-11-27T04:59:59Z 2008-04-25T02:27:39Z   0 0 09000064804dff39
FDA-2001-N-0175-0001 FDA Transportation Safety & Potentially Sedating or Impairing FDA-2001-N-0175 Meeting on 11/14-15/01 Notice NM-Notice of Meeting 2001-09-24T04:00:00Z 2001 9 2001-09-24T04:00:00Z 2001-12-18T04:59:59Z 2008-04-25T02:27:52Z   0 0 09000064804e0ed7
FDA-2000-D-0031-0001 FDA Electronic Records; Electronic Signatures, Validation FDA-2000-D-0031 FDA Notice NAD-Notice of Availability of Data 2001-09-24T04:00:00Z 2001 9 2001-09-24T04:00:00Z 2001-12-25T04:59:59Z 2008-04-25T01:12:34Z   0 0 09000064804aeb8d
FDA-2001-E-0151-0001 FDA Patent Extension for Trileptal, No. 4,559,174 FDA-2001-E-0151 Determination of Regulatory Review Period for Purposes of Patent Extension; Trileptal Notice General Notice 2001-09-24T04:00:00Z 2001 9 2001-09-24T04:00:00Z 2001-11-24T04:59:59Z 2025-09-15T16:10:58Z   0 0 09000064804ddd1d
FDA-2000-E-0239-0001 FDA Patent Extension Synercid #4,668,669 FDA-2000-E-0239 Determination of Regulatory Review Period for Purposes of Patent Extension; Synercid Notice General Notice 2001-09-21T04:00:00Z 2001 9 2001-09-21T04:00:00Z 2002-03-21T04:59:59Z 2025-07-09T16:09:54Z   0 0 09000064804d59f6
FDA-2001-E-0210-0001 FDA Kaletra, Patent Extension Application No.5,886,036 FDA-2001-E-0210 Determination of Regulatory Review Period for Purposes of Patent Extension; Kaletra Notice General Notice 2001-09-21T04:00:00Z 2001 9 2001-09-21T04:00:00Z 2002-03-21T04:59:59Z 2025-10-01T18:13:42Z   0 0 09000064804e41c2
FDA-2001-F-0180-0001 FDA use of mixture of peroxyacetic acid,octanoic acid,acetic FDA-2001-F-0180 Secondary Direct Food Additives Permitted in Food for Human Consumption Notice Notice of Final Rule 2001-09-21T04:00:00Z 2001 9 2001-09-21T04:00:00Z 2001-10-20T03:59:59Z 2025-11-06T20:46:42Z   0 0 09000064804e1878
FDA-2001-E-0234-0001 FDA Rescula, Patent Extension Application No. 5,221,763 FDA-2001-E-0234 Determination of Regulatory Review Period for Purposes of Patent Extension; Rescula Notice General Notice 2001-09-21T04:00:00Z 2001 9 2001-09-21T04:00:00Z 2002-03-21T04:59:59Z 2025-10-10T22:02:07Z   0 0 09000064804e6296
FDA-1996-P-0041-0001 FDA Refrain from granting exclusivity to NDAs for Fexofenadine FDA-1996-P-0041 Memorandum from FDA, Dave Read (HFD-7) to FDA Dockets Management Branch (HFA-305) Other Memorandum 2001-09-19T04:00:00Z 2001 9     2024-06-20T14:22:26Z   0 0 09000064804fc5e9
FDA-1996-P-0025-0001 FDA Reduce the Precense of Salmonella Enteritidis in Shell Eggs - CLOSED FDA-1996-P-0025 FDA Notice Notice of Availability 2001-09-18T04:00:00Z 2001 9 2001-09-18T04:00:00Z 2002-09-08T03:59:59Z 2016-05-31T16:17:22Z   0 0 09000064804faaa3
FDA-1998-N-0087-0001 FDA Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell FDA-1998-N-0087 FDA Notice NAD-Notice of Availability of Data 2001-09-18T04:00:00Z 2001 9 2001-09-18T04:00:00Z 2002-09-08T03:59:59Z 2008-05-16T21:37:51Z   0 0 0900006480585263
FDA-1994-P-0050-0002 FDA Amend Reference Amount for Baking Soda to read 1/8 tsp FDA-1994-P-0050 FDA Notice NAD-Notice of Availability of Data 2001-09-18T04:00:00Z 2001 9 2001-09-18T04:00:00Z 2002-09-08T03:59:59Z 2008-05-16T23:21:35Z   0 0 09000064804ffa38
FDA-1997-P-0017-0002 FDA Require that warning labels about risks of salmonella enteri FDA-1997-P-0017 Notice of Availability of Data re Small Entity Compliance Guide: “Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution;” Availability Notice Notice of Data Availability 2001-09-18T04:00:00Z 2001 9 2001-09-18T04:00:00Z 2002-09-08T03:59:59Z 2015-05-12T15:29:10Z   0 0 09000064805c9fc0
FDA-2001-E-0027-0001 FDA Angiomax, Patent Term Extension Application, No. 5,196,404 FDA-2001-E-0027 FDA/CDER to the U. S. Patent & Trademark Office - Letter Other LET-Letter 2001-09-12T04:00:00Z 2001 9     2010-01-29T15:43:16Z   0 0 09000064804b5c4f
FDA-2001-N-0047-0001 FDA Progress on implementing for the common technical document FDA-2001-N-0047 Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementing of the Common Technical Document; Public Meeting Notice Meeting 2001-09-12T04:00:00Z 2001 9     2025-01-30T17:36:45Z 01-22471 0 0 09000064804b78a3
FDA-2001-P-0216-0002 FDA To Remove False and Deceptive Labeling for Transderm Scope-CLOSED FDA-2001-P-0216 FDA/CDER to Paul, Hastings, Janofsky & Walker LLP Other LET-Letter 2001-09-11T04:00:00Z 2001 9     2008-04-25T02:38:56Z   0 0 09000064804e4a25
FDA-1999-P-0059-0003 FDA Reg/Guide to Label Medical Devices contain'g Phthalate Plasticizers-CLOSED FDA-1999-P-0059 FDA/CDRH to Sanford J. Lewis Other PDN-Petition Denial 2001-09-11T04:00:00Z 2001 9     2008-04-25T00:13:56Z   0 0 09000064804a671a
FDA-2001-P-0001-0002 FDA Rescind Approval of Solid Oral Dosage form of Metaxalone-CLOSED FDA-2001-P-0001 FDA/CDER to Mutual Pharmaceutical Company Other LET-Letter 2001-09-11T04:00:00Z 2001 9     2008-04-25T02:25:38Z   0 0 09000064804b3acf
FDA-2001-N-0133-0002 FDA Exemption From Premarket Notification Requirements; Class 1 FDA-2001-N-0133 Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices Notice Correction 2001-09-10T04:00:00Z 2001 9     2025-02-11T15:27:21Z 01-22577 0 0 09000064804dda85
FDA-2001-D-0061-0001 FDA Submitting Marketing Applications according to ICH/CTD Forma FDA-2001-D-0061 FDA Notice NAD-Notice of Availability of Data 2001-09-07T04:00:00Z 2001 9 2001-09-07T04:00:00Z 2001-11-06T04:59:59Z 2008-04-25T01:57:12Z   0 0 09000064804b80bb
FDA-2001-D-0161-0001 FDA Joint Metal/Polymer Constrained Cemented or Uncemented Prosh FDA-2001-D-0161 FDA Notice NAD-Notice of Availability of Data 2001-09-06T04:00:00Z 2001 9 2001-09-06T04:00:00Z 2001-12-06T04:59:59Z 2008-04-25T02:27:16Z   0 0 09000064804dfb31

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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);