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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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3,966 rows where agency_id = "FDA" and posted_year = 2011 sorted by posted_date descending

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  • 2011 · 3,966 ✖

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  • FDA · 3,966 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-D-0659-0034 FDA FDA-2008-D-0659 Guidance for Industry Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability Notice Notice of Availability 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2024-11-11T21:35:46Z 2011-33572 1 0 0900006480f8b716
FDA-2011-N-0002-0153 FDA FDA-2011-N-0002 Oncologic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2011-12-30T14:13:50Z 2011-33552 0 0 0900006480f8b71a
FDA-2011-D-0028-0003 FDA FDA-2011-D-0028 Medical Devices: Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions Rule Final Rule 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2011-12-30T14:31:25Z 2011-33588 0 0 0900006480f8b788
FDA-2011-N-0002-0155 FDA FDA-2011-N-0002 Oncologic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2011-12-30T14:38:03Z 2011-33548 0 0 0900006480f8b7c4
FDA-2011-D-0868-0001 FDA FDA-2011-D-0868 Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability Notice Notice of Availability 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2012-03-30T03:59:59Z 2020-04-29T00:35:05Z 2011-33550 0 0 0900006480f8b728
FDA-2011-D-0872-0002 FDA FDA-2011-D-0872 Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies Other Guidance 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2011-03-30T03:59:59Z 2011-12-30T13:38:31Z   0 0 0900006480f8b808
FDA-2011-N-0827-0001 FDA FDA-2011-N-0827 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labeling Requirements for Blood and Blood Components, Including Source Plasma; Revisions Notice General Notice 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2012-02-29T04:59:59Z 2011-12-30T14:28:59Z 2011-33555 0 0 0900006480f8b750
FDA-2011-D-0868-0002 FDA FDA-2011-D-0868 Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices Other Citizen Petition 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2024-11-07T23:55:25Z   1 0 0900006480f8b82a
FDA-2009-N-0247-0300 FDA FDA-2009-N-0247 Report on Good Guidance Practices Improving Efficiency and Transparency; Availability Notice Availability of Document 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2012-02-29T04:59:59Z 2011-12-30T14:36:05Z 2011-33573 0 0 0900006480f8b7c2
FDA-2011-N-0002-0154 FDA FDA-2011-N-0002 Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting Notice Meeting 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2011-12-30T14:26:10Z 2011-33561 0 0 0900006480f8b74c
FDA-2008-P-0555-0004 FDA FDA-2008-P-0555 Determinations that Drugs Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: HYCODAN Notice General Notice 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z   2011-12-30T13:50:53Z 2011-33549 0 0 0900006480f8b709
FDA-2011-D-0872-0001 FDA FDA-2011-D-0872 Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availabilty Notice Notice of Availability 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2012-03-30T03:59:59Z 2013-11-23T02:02:25Z 2011-33553 0 0 0900006480f8b6cb
FDA-2011-N-0619-0002 FDA FDA-2011-N-0619 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices Notice General Notice 2011-12-30T05:00:00Z 2011 12 2011-12-30T05:00:00Z 2012-01-31T04:59:59Z 2011-12-30T13:41:14Z 2011-33551 0 0 0900006480f8b6e5
FDA-1991-P-0165-0002 FDA Ban of Ergoloid Mesylates (Hydergine and others)-CLOSED FDA-1991-P-0165 FDA/CDRH Hydergine Memo, dated 12/28/2011 to Division of Dockets Management Other Memo 2011-12-29T05:00:00Z 2011 12 2011-12-29T05:00:00Z   2024-11-12T04:15:45Z   1 0 0900006480f8ae25
FDA-2011-N-0003-0057 FDA FDA-2011-N-0003 Freedom of Information Summary ANDA 200-318 Bimectin Pour-On (Ivermectin) Supporting & Related Material Reference (internal unless indicated) 2011-12-29T05:00:00Z 2011 12     2011-12-29T14:03:11Z   0 0 0900006480f8ad17
FDA-2011-N-0003-0056 FDA FDA-2011-N-0003 Ophthalmic and Topical Dosage Form New Animal Drugs: Ivermectin Topical Solution Rule Final Rule 2011-12-29T05:00:00Z 2011 12 2011-12-29T05:00:00Z   2011-12-29T13:58:17Z 2011-33382 0 0 0900006480f8acdf
FDA-2011-N-0345-0003 FDA FDA-2011-N-0345 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study on Consumer Responses to Nutrition Facts Labels, etc. Notice General Notice 2011-12-29T05:00:00Z 2011 12 2011-12-29T05:00:00Z 2012-01-31T04:59:59Z 2014-06-14T01:03:15Z 2011-33303 0 0 0900006480f8abb7
FDA-1995-P-0246-0002 FDA Warning On All Calcium Channel Blocking Drugs FDA-1995-P-0246 Memorandum from FDA CDER to FDA DDM Other Memorandum 2011-12-29T05:00:00Z 2011 12 2011-12-29T05:00:00Z   2025-09-15T23:09:53Z   1 0 0900006480f8ae55
FDA-1997-S-0006-1140 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Indiana Botanic Gardens, Inc., LET1140 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T19:17:21Z   0 0 0900006480f85d4d
FDA-1997-S-0006-1137 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 New Century Company LET1137 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T18:47:38Z   0 0 0900006480f85d47
FDA-2011-P-0913-0002 FDA FDA-2011-P-0913 Acknowledgement Letter to KVK-Tech, Inc. Other Acknowledgement Letter/Receipt 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T23:00:45Z   0 0 0900006480f847f9
FDA-2011-P-0923-0001 FDA FDA-2011-P-0923 Public Citizen Health Research Group - Citizen Petition Other Citizen Petition 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2012-08-08T18:44:33Z   0 0 0900006480f88963
FDA-2011-D-0652-0001 FDA FDA-2011-D-0652 Draft Guidances for Industry and Staff; Availability: 510(k) Program, Evaluating Substantial Equivalence in Premarket Notifications; Availability Notice Notice of Availability 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z 2012-04-27T03:59:59Z 2012-05-25T02:00:27Z 2011-33232 0 0 0900006480f8a26b
FDA-1997-S-0006-1141 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Cobalis Corporation LET1141 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T19:23:16Z   0 0 0900006480f85d4f
FDA-1997-S-0006-1136 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Country Life LET1136 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T17:27:48Z   0 0 0900006480f85d45
FDA-1997-S-0006-1143 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 New Chapter, Inc., LET1143 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T19:50:27Z   0 0 0900006480f85d53
FDA-2011-N-0912-0001 FDA FDA-2011-N-0912 Communications and Activities: Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed Notice General Notice 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z 2012-03-28T03:59:59Z 2012-05-04T12:01:27Z 2011-33188 0 0 0900006480f8a26a
FDA-2011-D-0652-0002 FDA FDA-2011-D-0652 Draft Guidance for Industry and Food and Drug Administration Staff The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Other Guidance 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z 2012-04-27T03:59:59Z 2014-09-27T01:07:24Z   0 0 0900006480f8a513
FDA-2011-D-0893-0002 FDA FDA-2011-D-0893 Draft Guidances for Industry and Staff Center for Devices and Radiological Health Appeals Processes Other Guidance 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z 2012-04-27T03:59:59Z 2011-12-28T16:23:06Z   0 0 0900006480f8a53c
FDA-2011-P-0923-0002 FDA FDA-2011-P-0923 Acknowledgement Letter to Public Citizen Health Research Group Other Acknowledgement Letter/Receipt 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T22:30:59Z   0 0 0900006480f88965
FDA-2010-D-0313-0018 FDA FDA-2010-D-0313 Guidance for Industry; Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation Other Guidance 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2024-11-07T01:40:00Z   1 0 0900006480f89bae
FDA-2011-P-0913-0001 FDA FDA-2011-P-0913 KVK-Tech, Inc. - Citizen Petition Other Citizen Petition 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2013-01-31T14:54:18Z   0 0 0900006480f847f5
FDA-1997-S-0006-1139 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Nuvilex, Inc., LET1139 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T19:10:07Z   0 0 0900006480f85d4b
FDA-1997-S-0006-1142 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 NatureGift (USA), Inc., LET1142 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T19:40:19Z   0 0 0900006480f85d51
FDA-1997-S-0006-1132 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Nutrition21, LET1132 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T16:34:57Z   0 0 0900006480f85d3d
FDA-1997-S-0006-1138 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Better Health Beverage (Foley & Lardner LLP.) LET1138 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T18:57:22Z   0 0 0900006480f85d49
FDA-2011-P-0734-0003 FDA FDA-2011-P-0734 FDA/CDER Response to Richard J. Miller - Petition Denial Other Denial of Petition 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T23:15:07Z   0 0 0900006480f8a924
FDA-2011-N-0002-0152 FDA FDA-2011-N-0002 Meetings: Cellular, Tissue, and Gene Therapies Advisory Committee Notice Meeting 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T20:10:31Z 2011-33220 0 0 0900006480f8a239
FDA-2007-N-0265-0007 FDA FDA-2007-N-0265 Temperature-Indicating Devices: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction Rule Correction 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T20:10:32Z 2011-33183 0 0 0900006480f8a284
FDA-2011-D-0893-0001 FDA FDA-2011-D-0893 Draft Guidances for Industry and Staff; Availability: Center for Devices and Radiological Health Appeals Processes Notice Notice of Availability 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z 2012-04-27T03:59:59Z 2014-01-13T17:39:02Z 2011-33230 0 0 0900006480f8a2c3
FDA-1997-S-0006-1134 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Source Naturals LET1134 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T17:14:06Z   0 0 0900006480f85d41
FDA-1997-S-0006-1133 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 New Century Company LET1133 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T17:07:01Z   0 0 0900006480f85d3f
FDA-2010-D-0313-0017 FDA FDA-2010-D-0313 Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability Notice Notice of Availability 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2024-11-07T01:39:58Z 2011-33292 1 0 0900006480f8a23c
FDA-1997-S-0006-1135 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 Planetary Ayurvedics LET1135 Response From FDA/CFSAN - Courtesy Letter Other Letter(s) 2011-12-28T05:00:00Z 2011 12 2011-12-28T05:00:00Z   2011-12-28T17:20:39Z   0 0 0900006480f85d43
FDA-2011-P-0852-0001 FDA FDA-2011-P-0852 Dr. S. Albert Edwards - Citizen Petition Other Citizen Petition 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2016-05-17T10:48:51Z   0 0 0900006480f74b19
FDA-2011-N-0002-0151 FDA FDA-2011-N-0002 Requests for Nominations: Voting Members on Public Advisory Panels or Committees Notice General Notice 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T16:38:57Z 2011-33060 0 0 0900006480f898b3
FDA-2011-N-0915-0001 FDA FDA-2011-N-0915 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products, etc. Notice General Notice 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z 2012-02-28T04:59:59Z 2011-12-27T16:45:58Z 2011-33140 0 0 0900006480f89156
FDA-2011-D-0787-0003 FDA FDA-2011-D-0787 Draft Guidance for Industry and Staff; Availability: Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies Notice Notice of Extension 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z 2012-03-10T04:59:59Z 2011-12-27T16:55:21Z 2011-33142 0 0 0900006480f89d41
FDA-2011-D-0790-0004 FDA FDA-2011-D-0790 Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations Notice Notice of Extension 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z 2012-03-10T04:59:59Z 2011-12-27T17:03:18Z 2011-33141 0 0 0900006480f89877
FDA-2011-P-0852-0002 FDA FDA-2011-P-0852 Acknowledgement Letter to Dr. S. Albert Edwards Other Acknowledgement Letter/Receipt 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T19:31:22Z   0 0 0900006480f74b64
FDA-2011-N-0002-0150 FDA FDA-2011-N-0002 Requests for Nominations: Food Advisory Committee Voting Members Notice General Notice 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T16:32:38Z 2011-33108 0 0 0900006480f89874
FDA-2011-N-0002-0149 FDA FDA-2011-N-0002 Endocrinologic and Metabolic Drugs Advisory Committee Meeting Notice Meeting 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T16:27:31Z 2011-33059 0 0 0900006480f89822
FDA-1978-N-0021-0042 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 FDA/CDER Maalox Total Relief Memo Meeting minutes and Quarterly Reports 12 9 11 Other Report 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T13:50:45Z   0 0 0900006480f899cc
FDA-2011-M-0866-0001 FDA FDA-2011-M-0866 Premarket Approval of Dako Denmark A/S HER2 CISH pharmDx™ Kit Other Approval 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T19:22:55Z   0 0 0900006480f80833
FDA-2011-V-0895-0002 FDA FDA-2011-V-0895 Acknowledgement Letter to Laser Sky Designs Other Acknowledgement Letter/Receipt 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T19:10:11Z   0 0 0900006480f805cf
FDA-2011-A-0346-0003 FDA FDA-2011-A-0346 Acknowledgement Letter to Radiation Safety Committee, University of California, Irvine Medical Center Other Acknowledgement Letter/Receipt 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2014-01-20T20:06:38Z   0 0 0900006480c6cd64
FDA-2010-P-0222-0003 FDA FDA-2010-P-0222 Alaunus Pharmaceutical, LLC - Withdrawal Other Withdrawal 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T18:47:04Z   0 0 0900006480f81d09
FDA-2010-P-0460-0003 FDA FDA-2010-P-0460 Alaunus Pharmaceutical, LLC - Amendment Other Amendment 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T17:54:48Z   0 0 0900006480f82074
FDA-2011-A-0346-0002 FDA FDA-2011-A-0346 Radiation Safety Committee, University of California, Irvine Medical Center - Advisory Opinion Other Advisory Opinion Petition 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2014-01-20T20:20:54Z   0 0 0900006480c6cd63
FDA-2011-V-0894-0002 FDA FDA-2011-V-0894 Acknowledgement Letter to Hypnotix Entertainment Other Acknowledgement Letter/Receipt 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T18:59:17Z   0 0 0900006480f805c8
FDA-2011-V-0894-0001 FDA FDA-2011-V-0894 Hypnotix Entertainment - Application for Variance Other Application for Variance (VAR) 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T18:59:17Z   0 0 0900006480f80586
FDA-2011-V-0895-0001 FDA FDA-2011-V-0895 Laser Sky Designs - Application for Variance Other Application for Variance (VAR) 2011-12-23T05:00:00Z 2011 12 2011-12-23T05:00:00Z   2011-12-23T19:10:10Z   0 0 0900006480f805cc
FDA-1977-N-0014-1438 FDA Penicillin in Animal Feeds - CLOSED FDA-1977-N-0014 Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed Notice Withdrawal 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2019-04-09T18:17:07Z 2011-32775 0 0 0900006480f87dc5
FDA-2011-N-0508-0002 FDA FDA-2011-N-0508 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing Notice General Notice 2011-12-22T05:00:00Z 2011 12     2011-12-22T17:02:14Z 2011-32777 0 0 0900006480f87cba
FDA-2011-A-0346-0001 FDA FDA-2011-A-0346 FDA/CDER Response to Radiation Safety Committee, University of California, Irvine Medical Center - Letter Other Letter(s) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-23T18:35:16Z   0 0 0900006480f854fd
FDA-2001-P-0123-0186 FDA Switch Status of Emergency Contraceptives from Rx to OTC FDA-2001-P-0123 FDA-CDER/ to Center for Reproductive Rights - Petition Denial Other Denial of Petition 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T18:07:45Z   0 0 0900006480f8816b
FDA-2007-N-0475-0035 FDA FDA-2007-N-0475 FDA/OC to Parties, from the Office of the Commissioner, December 15, 2011 - Letter Other Letter(s) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T18:45:27Z   0 0 0900006480f88195
FDA-2011-P-0552-0003 FDA FDA-2011-P-0552 Robert Wagner to FDA's Division of Dockets Management - Letter Other Letter(s) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T21:26:14Z   0 0 0900006480f8158b
FDA-2011-V-0896-0002 FDA FDA-2011-V-0896 Acknowledgement Letter to Patete Taylor Films, Inc. dba Boulevard Films Other Acknowledgement Letter/Receipt 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:21:12Z   0 0 0900006480f805fe
FDA-1977-N-0019-0067 FDA Penicillin-Containing Premixes FDA-1977-N-0019 Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed Notice Withdrawal 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2019-04-25T18:21:26Z 2011-32775 0 0 0900006480f87c5a
FDA-2011-V-0892-0001 FDA FDA-2011-V-0892 The Boys DJ - Application for Variance Other Application for Variance (VAR) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T16:45:22Z   0 0 0900006480f80581
FDA-2011-M-0865-0001 FDA FDA-2011-M-0865 Premarket Approval of PROMUS® Element™ Plus Everolimus-Eluting Platinum Coronary Stent System (Monorail™ and Over-The-Wire) Other Approval 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T20:58:20Z   0 0 0900006480f807f8
FDA-2011-V-0897-0002 FDA FDA-2011-V-0897 Acknowledgement Letter to NLFX Professional Other Acknowledgement Letter/Receipt 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:27:57Z   0 0 0900006480f80657
FDA-2011-V-0891-0002 FDA FDA-2011-V-0891 Acknowledgement Letter to Lore2mix Other Acknowledgement Letter/Receipt 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T15:26:26Z   0 0 0900006480f8057f
FDA-1977-N-0022-0146 FDA Tetracycline (Chlortetracycline & Oxytetracycline) Premixed FDA-1977-N-0022 Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed Notice Withdrawal 2011-12-22T05:00:00Z 2011 12     2011-12-22T16:45:03Z 2011-32775 0 0 0900006480f87ea8
FDA-2011-N-0511-0002 FDA FDA-2011-N-0511 Agency Information Collection Activities; Proposals, Submissions, andApprovals: Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components, etc. Notice General Notice 2011-12-22T05:00:00Z 2011 12     2011-12-22T14:02:15Z 2011-32778 0 0 0900006480f87c31
FDA-2011-N-0908-0001 FDA FDA-2011-N-0908 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice General Notice 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z 2012-02-22T04:59:59Z 2011-12-22T17:04:41Z 2011-32776 0 0 0900006480f87d15
FDA-2011-V-0897-0001 FDA FDA-2011-V-0897 NLFX Professional - Application for Variance Other Application for Variance (VAR) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:27:57Z   0 0 0900006480f80602
FDA-2011-N-0513-0010 FDA FDA-2011-N-0513 FDA/OC and ISTA Pharmaceuticals to G. Mathew Warren, FDA Senior Regulatory Counsel, December 16, 2011 - Letter Other Letter(s) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:27:13Z   0 0 0900006480f88124
FDA-1977-N-0224-0138 FDA Tetracycline-Proposal to Revise Regulations FDA-1977-N-0224 Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed Notice Withdrawal 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2019-04-29T15:42:47Z 2011-32775 0 0 0900006480f87ed5
FDA-2011-V-0892-0002 FDA FDA-2011-V-0892 Acknowledgement Letter to The Boys DJ Other Acknowledgement Letter/Receipt 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T16:45:22Z   0 0 0900006480f80584
FDA-2011-V-0891-0001 FDA FDA-2011-V-0891 Lore2mix - Application for Variance Other Application for Variance (VAR) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T15:26:26Z   0 0 0900006480f8057d
FDA-2011-N-0411-0003 FDA FDA-2011-N-0411 Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications: Bristol-Myers Squibb Co., et al.; Correction Notice Correction 2011-12-22T05:00:00Z 2011 12     2011-12-22T17:07:37Z 2011-32822 0 0 0900006480f87d1a
FDA-2010-P-0520-0007 FDA FDA-2010-P-0520 FDA/CDER/ to Extremity Innovations, Inc. - Petition Denial Other Denial of Petition 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T22:31:18Z   0 0 0900006480f882c3
FDA-2011-P-0552-0004 FDA FDA-2011-P-0552 FDA/CDRH Response to Robert Wagner - Petition Denial Other Denial of Petition 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T21:35:22Z   0 0 0900006480f878b0
FDA-2011-P-0645-0003 FDA FDA-2011-P-0645 FDA/CDER to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial Other Denial of Petition 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:22:27Z   0 0 0900006480f88146
FDA-2011-P-0484-0003 FDA FDA-2011-P-0484 Turtle Island Restoration (TIRN), and The Center for Biological Diversity (CBD) - Supplement Other Supplement (SUP) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2013-07-28T00:10:37Z   0 0 0900006480f81d0b
FDA-2011-P-0644-0003 FDA FDA-2011-P-0644 FDA-CDER/ to Center for Inquiry and Committee for Skeptical Inquiry - Petition Denial Other Denial of Petition 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:08:29Z   0 0 0900006480f8812b
FDA-2011-V-0896-0001 FDA FDA-2011-V-0896 Patete Taylor Films, Inc. dba Boulevard Films - Application for Variance Other Application for Variance (VAR) 2011-12-22T05:00:00Z 2011 12 2011-12-22T05:00:00Z   2011-12-22T17:21:12Z   0 0 0900006480f805fc
FDA-2011-N-0902-0001 FDA FDA-2011-N-0902 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prescription Drug Product Labeling; Medication Guide Requirements Notice 60 Day Proposed Information Collection 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z 2012-02-22T04:59:59Z 2011-12-21T21:40:13Z 2011-32548 0 0 0900006480f87038
FDA-2011-V-0877-0002 FDA FDA-2011-V-0877 Acknowledgement Letter to SLO DJ Other Acknowledgement Letter/Receipt 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T16:24:34Z   0 0 0900006480f7c980
FDA-2011-N-0656-0002 FDA FDA-2011-N-0656 Animal Drug User Fee Act; Reopening of Comment Period Notice Notice of Extension 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z 2013-01-16T04:59:59Z 2013-01-16T03:07:49Z 2011-32567 0 0 0900006480f87129
FDA-2011-V-0877-0001 FDA FDA-2011-V-0877 SLO DJ - Application for Variance Other Application for Variance (VAR) 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T16:24:34Z   0 0 0900006480f7c961
FDA-2011-N-0003-0054 FDA FDA-2011-N-0003 New Animal Drugs for Use in Animal Feeds: Monensin Rule Final Rule 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T22:06:14Z 2011-32427 0 0 0900006480f87099
FDA-2011-P-0804-0003 FDA FDA-2011-P-0804 Bruno Independent Living Aids, Inc. - Letter Other Letter(s) 2011-12-21T05:00:00Z 2011 12 2011-11-09T05:00:00Z   2013-08-11T04:49:15Z   0 0 0900006480f7f21f
FDA-2011-N-0003-0055 FDA FDA-2011-N-0003 New Animal Drugs: Change of Sponsor; Zinc Gluconate Rule Final Rule 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T22:32:43Z 2011-32591 0 0 0900006480f87170
FDA-2011-V-0876-0002 FDA FDA-2011-V-0876 Acknowledgement Letter to Painted Bride Art Center Other Acknowledgement Letter/Receipt 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T16:19:26Z   0 0 0900006480f7c94d
FDA-2011-N-0842-0001 FDA FDA-2011-N-0842 Gluten in Drug Products Notice General Notice 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z 2012-03-21T03:59:59Z 2011-12-21T21:31:22Z 2011-32551 0 0 0900006480f87037
FDA-2011-N-0655-0003 FDA FDA-2011-N-0655 Animal Generic Drug User Fee Act; Reopening of Comment Period Notice Notice of Extension 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z 2013-01-16T04:59:59Z 2012-12-11T03:01:51Z 2011-32565 0 0 0900006480f8703b
FDA-2011-V-0876-0001 FDA FDA-2011-V-0876 Painted Bride Art Center - Application for Variance Other Application for Variance (VAR) 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T16:19:25Z   0 0 0900006480f7c91f

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    id TEXT PRIMARY KEY,
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    docket_id TEXT REFERENCES dockets(id),
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    posted_month INTEGER,
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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);