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

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778 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2020 sorted by posted_date descending

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posted_year 1

  • 2020 · 778 ✖

document_type 1

  • Notice · 778 ✖

agency_id 1

  • FDA · 778 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0124-0410 FDA None FDA-2016-N-0124 Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Notice Notice of Availability 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2020-12-31T14:14:51Z 2020-28929 0 0 09000064849d654d
FDA-2014-D-1804-0073 FDA None FDA-2014-D-1804 Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-12-30T05:00:00Z 2020 12 2020-12-30T05:00:00Z   2020-12-30T13:31:56Z 2020-28816 0 0 09000064849d16c7
FDA-2018-N-3233-0002 FDA None FDA-2018-N-3233 Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee Notice Request for Nominations 2020-12-30T05:00:00Z 2020 12 2020-12-30T05:00:00Z   2020-12-30T13:28:30Z 2020-28833 0 0 09000064849d18c9
FDA-2020-N-2246-0001 FDA None FDA-2020-N-2246 Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 Notice Announcement 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:03:53Z 2020-28714 0 0 09000064849cfd28
FDA-2010-N-0493-0013 FDA None FDA-2010-N-0493 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:10:19Z 2020-28608 0 0 09000064849cfdc6
FDA-2017-N-2021-0007 FDA None FDA-2017-N-2021 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:10:55Z 2020-28608 0 0 09000064849cfe9f
FDA-2017-N-1095-0009 FDA None FDA-2017-N-1095 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:12:08Z 2020-28608 0 0 09000064849cfe9d
FDA-2012-N-0197-0010 FDA None FDA-2012-N-0197 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:12:34Z 2020-28608 0 0 09000064849cfe9c
FDA-2011-N-0424-0011 FDA None FDA-2011-N-0424 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2020-12-29T05:00:00Z 2020 12 2020-12-29T05:00:00Z   2020-12-29T17:11:23Z 2020-28608 0 0 09000064849cfe9e
FDA-2020-N-2252-0001 FDA None FDA-2020-N-2252 Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments Notice Request for Comments 2020-12-28T05:00:00Z 2020 12 2020-12-28T05:00:00Z 2021-03-30T03:59:59Z 2021-03-30T01:00:27Z 2020-28602 0 0 09000064849cc7ab
FDA-2020-D-0530-0668 FDA None FDA-2020-D-0530 Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Comment Period Notice Notice of Availability 2020-12-28T05:00:00Z 2020 12 2020-12-28T05:00:00Z 2021-02-26T04:59:59Z 2021-02-27T02:00:26Z 2020-28559 0 0 09000064849cc892
FDA-2017-D-4303-0003 FDA None FDA-2017-D-4303 Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry; Availability Notice Notice of Availability 2020-12-28T05:00:00Z 2020 12 2020-12-28T05:00:00Z   2020-12-28T16:56:08Z 2020-28560 0 0 09000064849cc7af
FDA-2020-N-1440-0001 FDA None FDA-2020-N-1440 Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2020-12-28T05:00:00Z 2020 12 2020-12-28T05:00:00Z 2021-02-09T04:59:59Z 2021-02-10T02:00:46Z 2020-28558 0 0 09000064849cc88e
FDA-2020-N-0008-0022 FDA None FDA-2020-N-0008 Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee; Renewal Notice Renewals 2020-12-28T05:00:00Z 2020 12 2020-12-28T05:00:00Z   2020-12-28T16:53:17Z 2020-28561 0 0 09000064849cc890
FDA-2020-N-2272-0001 FDA None FDA-2020-N-2272 Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications Notice Withdrawal 2020-12-23T05:00:00Z 2020 12 2020-12-23T05:00:00Z   2020-12-23T15:00:57Z 2020-28346 0 0 09000064849c0835
FDA-2010-N-0155-0253 FDA None FDA-2010-N-0155 Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive Notice 60 Day Proposed Information Collection 2020-12-23T05:00:00Z 2020 12 2020-12-23T05:00:00Z 2021-02-23T04:59:59Z 2020-12-23T15:07:58Z 2020-28353 0 0 09000064849c0f93
FDA-2020-N-2267-0001 FDA None FDA-2020-N-2267 Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets Notice Withdrawal 2020-12-23T05:00:00Z 2020 12 2020-12-23T05:00:00Z   2020-12-23T15:11:29Z 2020-28283 0 0 09000064849c0fe7
FDA-2014-N-0386-0005 FDA None FDA-2014-N-0386 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs Notice 30 Day Proposed Information Collection 2020-12-23T05:00:00Z 2020 12 2020-12-23T05:00:00Z 2021-01-23T04:59:59Z 2021-01-23T02:02:30Z 2020-28349 0 0 09000064849c0f39
FDA-2010-N-0161-0012 FDA None FDA-2010-N-0161 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates Notice 30 Day Proposed Information Collection 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z 2021-01-21T04:59:59Z 2020-12-21T13:22:19Z 2020-28064 0 0 09000064849ae940
FDA-2020-N-1866-0002 FDA None FDA-2020-N-1866 Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications; Correction Notice Correction 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z   2020-12-21T13:44:00Z 2020-28081 0 0 09000064849aef3a
FDA-2020-P-1650-0003 FDA None FDA-2020-P-1650 Determination That DOBUTREX (Dobutamine Hydrochloride), Equivalent 12.5 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z   2020-12-21T13:53:01Z 2020-28080 0 0 09000064849aefda
FDA-2018-N-0417-0003 FDA None FDA-2018-N-0417 Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee Notice Advisory Committee 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z   2020-12-21T13:33:01Z 2020-28054 0 0 09000064849aeb78
FDA-2020-N-0001-0007 FDA None FDA-2020-N-0001 Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting Notice Public Meetings 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z   2020-12-21T13:28:07Z 2020-28069 0 0 09000064849ae945
FDA-2020-N-2217-0001 FDA None FDA-2020-N-2217 Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use Notice 60 Day Proposed Information Collection 2020-12-21T05:00:00Z 2020 12 2020-12-21T05:00:00Z 2021-02-20T04:59:59Z 2021-02-20T02:00:29Z 2020-28068 0 0 09000064849aef84
FDA-2014-N-1072-0011 FDA None FDA-2014-N-1072 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs Notice 30 Day Proposed Information Collection 2020-12-18T05:00:00Z 2020 12 2020-12-18T05:00:00Z 2021-01-20T04:59:59Z 2020-12-18T14:46:28Z 2020-27963 0 0 09000064849a75bd
FDA-2020-N-1359-0021 FDA None FDA-2020-N-1359 Sugars That Are Metabolized Differently Than Traditional Sugars; Extension of Comment Period Notice Extension of Comment Period 2020-12-18T05:00:00Z 2020 12 2020-12-18T05:00:00Z 2020-10-20T03:59:59Z 2020-12-18T14:50:26Z 2020-27749 0 0 09000064849a7689
FDA-2020-N-0026-0008 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher: Rare Pediatric Disease Product Notice General Notice 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T18:16:44Z 2020-27760 0 0 09000064849a4513
FDA-2013-N-0520-0011 FDA None FDA-2013-N-0520 Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed Notice 60 Day Proposed Information Collection 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z 2021-02-17T04:59:59Z 2020-12-17T18:14:11Z 2020-27746 0 0 09000064849a43f7
FDA-2020-D-2214-0001 FDA None FDA-2020-D-2214 Dry Eye: Developing Drugs for Treatment; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z 2021-03-18T03:59:59Z 2022-09-12T19:47:56Z 2020-27762 0 0 09000064849a4491
FDA-2019-D-3679-0014 FDA None FDA-2019-D-3679 Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability Notice Notice of Availability 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T19:10:20Z 2020-27813 0 0 09000064849a443c
FDA-2020-N-0026-0007 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T16:38:06Z 2020-27778 0 0 09000064849a448f
FDA-2018-N-0074-0005 FDA None FDA-2018-N-0074 Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications Notice 60 Day Proposed Information Collection 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z 2021-02-17T04:59:59Z 2020-12-17T18:08:40Z 2020-27748 0 0 09000064849a43bc
FDA-2014-D-1167-0021 FDA None FDA-2014-D-1167 Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability Notice Notice of Availability 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T19:19:44Z 2020-27810 0 0 09000064849a4518
FDA-2020-N-2197-0001 FDA None FDA-2020-N-2197 VistaPharm, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications Notice Withdrawal 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T14:19:32Z 2020-27303 0 0 0900006484998516
FDA-2015-D-3787-0015 FDA None FDA-2015-D-3787 Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Notice Extension of Comment Period 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z 2021-02-17T04:59:59Z 2020-12-11T14:25:30Z 2020-27350 0 0 09000064849985cd
FDA-2019-D-1650-0008 FDA None FDA-2019-D-1650 Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:54:17Z 2020-27248 0 0 0900006484998722
FDA-2019-D-1647-0005 FDA None FDA-2019-D-1647 Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:51:06Z 2020-27248 0 0 0900006484998515
FDA-2019-N-4203-0033 FDA None FDA-2019-N-4203 Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Renewal Notice Advisory Committee 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T14:22:38Z 2020-27289 0 0 0900006484998591
FDA-2020-D-0064-0005 FDA None FDA-2020-D-0064 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices; Guidance for Industry; Availability Notice Notice of Availability 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:31:44Z 2020-27256 0 0 0900006484998048
FDA-2020-N-2226-0001 FDA None FDA-2020-N-2226 Cheese Products Deviating from Identity Standard; Temporary Permit for Market Testing Notice General Notice 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:46:57Z 2020-27197 0 0 0900006484998093
FDA-2019-D-1652-0008 FDA None FDA-2019-D-1652 Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:52:37Z 2020-27248 0 0 0900006484998721
FDA-2010-D-0529-0033 FDA None FDA-2010-D-0529 Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction Notice Notice of Availability 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T13:39:39Z 2020-27288 0 0 090000648499804d
FDA-2020-N-2196-0001 FDA None FDA-2020-N-2196 Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams Notice Withdrawal 2020-12-10T05:00:00Z 2020 12 2020-12-10T05:00:00Z   2020-12-10T12:59:11Z 2020-27082 0 0 0900006484995521
FDA-2020-N-2227-0001 FDA None FDA-2020-N-2227 Food and Drug Administration FiscalbYear 2020 Performance Review Board Notice Announcement 2020-12-10T05:00:00Z 2020 12 2020-12-10T05:00:00Z   2020-12-10T12:50:15Z 2020-27123 0 0 090000648499376c
FDA-2014-N-1076-0007 FDA None FDA-2014-N-1076 Agency Information Collection Activities; Proposed Co llection; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice Notice 60 Day Proposed Information Collection 2020-12-09T05:00:00Z 2020 12 2020-12-09T05:00:00Z 2021-02-09T04:59:59Z 2020-12-09T13:49:47Z 2020-27060 0 0 090000648498fb9a
FDA-2020-D-0770-0001 FDA None FDA-2020-D-0770 Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-12-09T05:00:00Z 2020 12 2020-12-09T05:00:00Z   2021-03-15T21:11:29Z 2020-27057 0 0 090000648498fbf4
FDA-2014-D-0622-0020 FDA None FDA-2014-D-0622 Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability Notice Notice of Availability 2020-12-09T05:00:00Z 2020 12 2020-12-09T05:00:00Z   2020-12-09T13:40:47Z 2020-27058 0 0 090000648498fb58
FDA-2020-N-0026-0006 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-12-07T05:00:00Z 2020 12 2020-12-07T05:00:00Z   2020-12-07T16:10:20Z 2020-26801 0 0 0900006484989f80
FDA-2019-N-5900-0012 FDA None FDA-2019-N-5900 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Explicitness of Payment in Directto-Consumer Promotion Notice 30 Day Proposed Information Collection 2020-12-07T05:00:00Z 2020 12 2020-12-07T05:00:00Z 2021-01-07T04:59:59Z 2020-12-08T02:00:52Z 2020-26799 0 0 0900006484989f3f
FDA-2018-N-1768-0002 FDA None FDA-2018-N-1768 Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal Notice Committee Renewal 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T14:09:26Z 2020-26696 0 0 0900006484985b73
FDA-2020-N-2216-0001 FDA None FDA-2020-N-2216 Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID–19; Availability Notice Announcement 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T13:25:15Z 2020-26697 0 0 0900006484985a7a
FDA-2017-N-6397-0010 FDA None FDA-2017-N-6397 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Notice 60 Day Proposed Information Collection 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z 2021-02-03T04:59:59Z 2021-01-26T02:01:19Z 2020-26695 0 0 0900006484985c24
FDA-2019-D-4739-0016 FDA None FDA-2019-D-4739 Requesting FDA Feedback on Combination Products; Guidance for Industry and FDA Staff; Availability Notice Notice of Availability 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T14:14:50Z 2020-26700 0 0 0900006484985b24
FDA-2017-D-5739-0009 FDA None FDA-2017-D-5739 Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction Notice Notice of Availability 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T13:53:26Z 2020-26691 0 0 0900006484985c2a
FDA-2017-P-5787-0235 FDA None FDA-2017-P-5787 Petition Supplement 2 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:17:17Z   0 0 0900006484984494
FDA-2017-P-5787-0234 FDA None FDA-2017-P-5787 Petition Supplement 1 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:16:41Z   0 0 0900006484984493
FDA-2020-N-2242-0001 FDA None FDA-2020-N-2242 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Public Hearings 2020-12-03T05:00:00Z 2020 12 2020-12-03T05:00:00Z 2020-12-17T04:59:59Z 2020-12-18T02:00:39Z 2020-26704 0 0 090000648498419b
FDA-2011-N-0016-0013 FDA None FDA-2011-N-0016 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z   2020-12-02T15:02:15Z 2020-26571 0 0 09000064849819f5
FDA-2010-N-0622-0011 FDA None FDA-2010-N-0622 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z   2020-12-02T15:04:53Z 2020-26571 0 0 09000064849819f3
FDA-2009-N-0501-0023 FDA None FDA-2009-N-0501 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-12-02T05:00:00Z 2020 12 2023-04-04T04:00:00Z   2023-04-04T15:33:25Z 2020-26571 0 0 09000064849819f8
FDA-2019-N-6098-0009 FDA None FDA-2019-N-6098 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z   2020-12-02T14:46:49Z 2020-26571 0 0 09000064849819f6
FDA-1987-P-0074-0007 FDA Canned Pacific Salmon Deviating From Identity Standard FDA-1987-P-0074 Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit Notice Correction 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z   2020-12-02T14:37:41Z 2020-26533 0 0 0900006484981905
FDA-2010-N-0190-0004 FDA None FDA-2010-N-0190 Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements Notice 60 Day Proposed Information Collection 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z 2021-02-02T04:59:59Z 2021-02-02T02:00:58Z 2020-26537 0 0 0900006484981343
FDA-2013-N-1119-0015 FDA None FDA-2013-N-1119 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2020-12-02T05:00:00Z 2020 12 2020-12-02T05:00:00Z   2020-12-02T14:52:37Z 2020-26571 0 0 090000648498138f
FDA-2019-N-1845-0136 FDA None FDA-2019-N-1845 Fixed-Quantity Unit-of-Use Blister-Packaging for Certain Immediate- Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments; Reopening of the Comment Period and Provision of Additional Information and Analysis Notice Request for Comments 2020-12-01T05:00:00Z 2020 12 2020-12-01T05:00:00Z 2021-02-02T04:59:59Z 2021-02-02T02:00:58Z 2020-26504 0 0 090000648497f5d1
FDA-2020-D-1794-0001 FDA None FDA-2020-D-1794 Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-12-01T05:00:00Z 2020 12 2020-12-01T05:00:00Z 2021-03-02T04:59:59Z 2021-03-02T02:00:56Z 2020-26510 0 0 090000648497f79e
FDA-2011-N-0076-0013 FDA None FDA-2011-N-0076 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures Notice 30 Day Proposed Information Collection 2020-12-01T05:00:00Z 2020 12 2020-12-01T05:00:00Z 2021-01-01T04:59:59Z 2023-08-31T17:40:52Z 2020-26487 0 0 090000648497f743
FDA-2020-N-1671-0003 FDA None FDA-2020-N-1671 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies Notice 30 Day Proposed Information Collection 2020-12-01T05:00:00Z 2020 12 2020-12-01T05:00:00Z 2021-01-01T04:59:59Z 2020-12-01T15:39:21Z 2020-26502 0 0 090000648497f7a5
FDA-2020-N-1337-0003 FDA None FDA-2020-N-1337 John Kapoor: Final Debarment Order Notice Statutory Debarment 2020-11-30T05:00:00Z 2020 11 2020-11-30T05:00:00Z   2020-11-30T13:47:21Z 2020-26262 0 0 090000648497c3e1
FDA-2019-N-4248-0002 FDA None FDA-2019-N-4248 Barry J. Cadden: Final Debarment Order Notice Statutory Debarment 2020-11-30T05:00:00Z 2020 11 2020-11-30T05:00:00Z   2020-11-30T13:26:47Z 2020-26255 0 0 090000648497c22c
FDA-2020-N-1255-0002 FDA None FDA-2020-N-1255 Tuan Anh Tran: Final Debarment Order Notice Statutory Debarment 2020-11-30T05:00:00Z 2020 11 2020-11-30T05:00:00Z   2020-11-30T13:41:46Z 2020-26250 0 0 090000648497c353
FDA-2020-N-1347-0002 FDA None FDA-2020-N-1347 Michael L. Babich: Final Debarment Order Notice Statutory Debarment 2020-11-27T05:00:00Z 2020 11 2020-11-27T05:00:00Z   2020-11-27T13:49:00Z 2020-26226 0 0 09000064849787fd
FDA-2020-N-1736-0009 FDA None FDA-2020-N-1736 Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Extension of Comment Period Notice Extension of Comment Period 2020-11-27T05:00:00Z 2020 11 2020-11-27T05:00:00Z   2021-04-03T01:00:54Z 2020-26182 0 0 09000064849787ac
FDA-2020-N-1898-0036 FDA None FDA-2020-N-1898 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Public Meetings 2020-11-27T05:00:00Z 2020 11 2020-11-27T05:00:00Z 2020-12-10T04:59:59Z 2020-12-11T02:00:44Z 2020-26229 0 0 0900006484978404
FDA-2016-D-4437-0005 FDA None FDA-2016-D-4437 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Guidance for Industry; Availability Notice Notice of Availability 2020-11-27T05:00:00Z 2020 11 2020-11-27T05:00:00Z   2020-11-27T13:36:35Z 2020-26183 0 0 09000064849787ae
FDA-2019-N-3077-0013 FDA None FDA-2019-N-3077 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities Notice 30 Day Proposed Information Collection 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z 2020-12-29T04:59:59Z 2020-12-27T02:02:12Z 2020-26066 0 0 0900006484975894
FDA-2020-N-1677-0005 FDA None FDA-2020-N-1677 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle Notice 30 Day Proposed Information Collection 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z 2020-12-29T04:59:59Z 2020-11-26T02:00:36Z 2020-26059 0 0 0900006484975e11
FDA-2009-N-0380-0012 FDA None FDA-2009-N-0380 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products Notice 30 Day Proposed Information Collection 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z 2020-12-29T04:59:59Z 2020-11-25T14:13:57Z 2020-26062 0 0 09000064849757af
FDA-2017-D-5739-0007 FDA None FDA-2017-D-5739 Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability Notice Notice of Availability 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z   2020-11-25T14:24:31Z 2020-26050 0 0 0900006484975d73
FDA-2010-D-0529-0031 FDA None FDA-2010-D-0529 Qualification Process for Drug Development Tools; Guidance for Industry; Availability Notice Notice of Availability 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z   2020-11-25T14:16:53Z 2020-26051 0 0 090000648497584a
FDA-2020-Z-2200-0002 FDA None FDA-2020-Z-2200 Termination of the Food and Drug Administration's Unapproved Drugs Initiative Notice General Notice 2020-11-25T05:00:00Z 2020 11 2020-11-25T05:00:00Z   2020-11-27T16:25:15Z 2020-26133 0 0 0900006484975dc2
FDA-2020-D-1848-0001 FDA None FDA-2020-D-1848 Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-11-23T05:00:00Z 2020 11 2020-11-23T05:00:00Z 2021-02-23T04:59:59Z 2021-02-23T02:00:36Z 2020-25744 0 0 090000648497009b
FDA-2018-D-1752-0028 FDA None FDA-2018-D-1752 Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-11-23T05:00:00Z 2020 11 2020-11-23T05:00:00Z   2020-11-23T14:18:01Z 2020-25719 0 0 0900006484970634
FDA-2017-N-6455-0004 FDA None FDA-2017-N-6455 Agency Information Collection Activities; Proposed Collection; Comment Request; Consultation Procedures: Foods Derived From New Plant Varieties Notice 60 Day Proposed Information Collection 2020-11-23T05:00:00Z 2020 11 2020-11-23T05:00:00Z 2021-01-23T04:59:59Z 2020-11-23T14:11:23Z 2020-25752 0 0 0900006484970095
FDA-2018-D-0943-0010 FDA None FDA-2018-D-0943 Elemental Impurities in Animal Drug Products—Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2020-11-23T05:00:00Z 2020 11 2020-11-23T05:00:00Z   2020-11-23T14:16:00Z 2020-25726 0 0 0900006484970560
FDA-2020-D-2107-0001 FDA None FDA-2020-D-2107 Cross Labeling Oncology Drugs in Combination Drug Regimens; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z 2021-01-20T04:59:59Z 2021-01-20T02:02:52Z 2020-25737 0 0 090000648496ac8d
FDA-2020-N-1584-0002 FDA None FDA-2020-N-1584 Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability Notice General Notice 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z   2020-11-20T15:33:21Z 2020-25603 0 0 090000648496ac8a
FDA-2011-D-0611-0081 FDA None FDA-2011-D-0611 Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z 2021-01-20T04:59:59Z 2021-01-21T02:00:45Z 2020-25606 0 0 090000648496ac54
FDA-2020-N-1394-0002 FDA None FDA-2020-N-1394 Richard M. Simon: Final Debarment Order Notice Statutory Debarment 2020-11-19T05:00:00Z 2020 11 2020-11-19T05:00:00Z   2020-11-19T14:02:33Z 2020-25601 0 0 0900006484968606
FDA-2007-D-0369-0510 FDA None FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2020-11-19T05:00:00Z 2020 11 2020-11-19T05:00:00Z 2021-01-20T04:59:59Z 2020-11-19T14:06:28Z 2020-25602 0 0 09000064849686e1
FDA-2013-N-1429-0020 FDA None FDA-2013-N-1429 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees Notice 30 Day Proposed Information Collection 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z 2020-12-19T04:59:59Z 2023-07-20T14:23:39Z 2020-25411 0 0 0900006484966148
FDA-2020-D-1137-0060 FDA None FDA-2020-D-1137 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z   2021-04-03T01:00:48Z 2020-25399 0 0 0900006484966237
FDA-2013-D-0575-0040 FDA None FDA-2013-D-0575 Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions— Drugs and Biologics Notice 60 Day Proposed Information Collection 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z 2021-01-20T04:59:59Z 2021-01-21T02:00:41Z 2020-25414 0 0 090000648496582e
FDA-2007-D-0369-0508 FDA None FDA-2007-D-0369 Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability Notice Notice of Availability 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z 2021-01-20T04:59:59Z 2021-01-16T02:01:08Z 2020-25412 0 0 09000064849661a3
FDA-2020-D-1138-0132 FDA None FDA-2020-D-1138 Guidance Documents Related to Coronavirus Disease 2019; Availability Notice Notice of Availability 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z   2020-11-18T13:30:14Z 2020-25399 0 0 0900006484965ca4
FDA-2019-N-5843-0002 FDA None FDA-2019-N-5843 Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction Notice Correction 2020-11-18T05:00:00Z 2020 11 2020-11-18T05:00:00Z   2020-11-18T13:15:03Z 2020-25413 0 0 09000064849661a2
FDA-2015-D-3787-0008 FDA None FDA-2015-D-3787 Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-11-17T05:00:00Z 2020 11 2020-11-17T05:00:00Z 2021-01-20T04:59:59Z 2021-01-15T02:01:09Z 2020-25306 0 0 0900006484963731
FDA-2020-N-2030-0001 FDA None FDA-2020-N-2030 Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug Notice 60 Day Proposed Information Collection 2020-11-16T05:00:00Z 2020 11 2020-11-16T05:00:00Z 2021-01-16T04:59:59Z 2020-11-16T13:30:51Z 2020-25239 0 0 0900006484960494
FDA-2019-D-3592-0010 FDA None FDA-2019-D-3592 Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-11-16T05:00:00Z 2020 11 2020-11-16T05:00:00Z   2020-11-16T13:40:06Z 2020-25238 0 0 0900006484960498
FDA-2009-D-0052-0016 FDA None FDA-2009-D-0052 Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability Notice Notice of Availability 2020-11-13T05:00:00Z 2020 11 2020-11-13T05:00:00Z   2020-11-13T15:21:33Z 2020-25131 0 0 090000648495bcbe

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CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;