documents

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

1,085 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2018 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_month, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 1

  • 2018 · 1,085 ✖

document_type 1

  • Notice · 1,085 ✖

agency_id 1

  • FDA · 1,085 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-E-6016-0006 FDA FDA-2017-E-6016 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-02-27T04:59:59Z 2019-01-09T02:01:46Z 2018-28221 0 0 09000064839d2140
FDA-2017-E-6017-0006 FDA FDA-2017-E-6017 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T23:00:56Z 2018-28221 0 0 09000064839d2141
FDA-2017-E-6708-0006 FDA FDA-2017-E-6708 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:12:00Z 2018-28216 0 0 09000064839d2146
FDA-2017-E-6701-0006 FDA FDA-2017-E-6701 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-31T05:00:00Z 2018 12 2018-12-31T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:19:56Z 2018-28216 0 0 09000064839d2147
FDA-2007-D-0369-0459 FDA FDA-2007-D-0369 Product-Specific Guidance for Linaclotide; Draft Guidance for Industry Notice Notice of Availability 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-02-27T02:04:39Z 2018-28213 0 0 09000064839cbf71
FDA-2017-E-6003-0006 FDA FDA-2017-E-6003 Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:10:48Z 2018-28221 0 0 09000064839cbe98
FDA-2018-D-4662-0001 FDA FDA-2018-D-4662 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV Notice Notice of Availability 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-01-14T19:29:13Z 2018-28219 0 0 09000064839cbf33
FDA-2018-N-3037-0002 FDA FDA-2018-N-3037 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications Notice 30 Day Proposed Information Collection 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-01-29T04:59:59Z 2019-01-10T02:46:59Z 2018-28252 0 0 09000064839cbd39
FDA-2017-E-6736-0005 FDA FDA-2017-E-6736 Determination of Regulatory Review Period for Purposes of Patent Extension; XERMELO Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:26:53Z 2018-28218 0 0 09000064839cbee3
FDA-2012-N-0197-0005 FDA FDA-2012-N-0197 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Shortages Data Collection System Notice Request for Comments 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T20:58:41Z 2018-28235 0 0 09000064839cbe96
FDA-2017-E-6002-0006 FDA FDA-2017-E-6002 Determination of Regulatory Review Period for Purposes of Patent Extension; RUBRACA Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2018-12-31T21:05:16Z 2018-28217 0 0 09000064839cbe97
FDA-2012-N-0536-0008 FDA FDA-2012-N-0536 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 Notice 60 Day Proposed Information Collection 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-02-27T04:59:59Z 2019-07-17T12:49:50Z 2018-28220 0 0 09000064839cc098
FDA-2017-E-6700-0006 FDA FDA-2017-E-6700 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: RYDAPT Notice Determinations 2018-12-28T05:00:00Z 2018 12 2018-12-28T05:00:00Z 2019-06-27T03:59:59Z 2024-03-07T21:04:21Z 2018-28216 0 0 09000064839cbfba
FDA-2018-N-1989-0001 FDA FDA-2018-N-1989 Ranjan Bhandari: Debarment Order Notice Statutory Debarment 2018-12-27T05:00:00Z 2018 12 2018-12-27T05:00:00Z   2018-12-31T20:39:45Z 2018-27951 0 0 09000064839c8820
FDA-2018-N-4428-0001 FDA FDA-2018-N-4428 Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application Notice 60 Day Proposed Information Collection 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-26T04:59:59Z 2019-01-10T02:17:47Z 2018-27812 0 0 09000064839c4daf
FDA-2017-D-3001-0235 FDA FDA-2017-D-3001 Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A. Notice Announcement 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-12T04:59:59Z 2019-02-27T02:06:18Z 2018-27807 0 0 09000064839c4e5f
FDA-2017-E-5040-0006 FDA FDA-2017-E-5040 Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN Notice Determinations 2018-12-26T05:00:00Z 2018 12 2018-12-26T05:00:00Z 2019-02-26T04:59:59Z 2019-01-10T02:33:03Z 2018-27805 0 0 09000064839c4db3
FDA-2018-D-4455-0001 FDA FDA-2018-D-4455 Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders; Availability Notice Notice of Availability 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-03-22T03:59:59Z 2019-03-23T01:00:52Z 2018-27657 0 0 09000064839be12e
FDA-2016-D-4308-0021 FDA FDA-2016-D-4308 Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability Notice Notice of Availability 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z   2018-12-21T14:24:57Z 2018-27654 0 0 09000064839be0a5
FDA-2017-E-3592-0005 FDA FDA-2017-E-3592 Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD Notice Determinations 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-06-20T03:59:59Z 2019-03-02T02:06:18Z 2018-27678 0 0 09000064839be9b4
FDA-2018-N-3552-0015 FDA FDA-2018-N-3552 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Cigarette Warnings Notice 30 Day Proposed Information Collection 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-01-23T04:59:59Z 2019-01-23T02:00:31Z 2018-27658 0 0 09000064839be141
FDA-2013-N-0520-0006 FDA FDA-2013-N-0520 Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Notice 60 Day Proposed Information Collection 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-02-20T04:59:59Z 2019-01-30T02:07:32Z 2018-27656 0 0 09000064839be0b7
FDA-2017-E-3616-0005 FDA FDA-2017-E-3616 Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD Notice Determinations 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-06-20T03:59:59Z 2019-03-02T02:07:21Z 2018-27678 0 0 09000064839be0db
FDA-2018-N-4465-0001 FDA FDA-2018-N-4465 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices Notice 60 Day Proposed Information Collection 2018-12-21T05:00:00Z 2018 12 2018-12-21T05:00:00Z 2019-02-20T04:59:59Z 2018-12-21T14:22:29Z 2018-27655 0 0 09000064839be279
FDA-2017-D-5966-0012 FDA FDA-2017-D-5966 Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-12-19T05:00:00Z 2018 12 2018-12-19T05:00:00Z   2024-11-12T22:53:05Z 2018-27433 1 0 09000064839b2697
FDA-2018-N-4627-0001 FDA FDA-2018-N-4627 Intent To Consider the Appropriate Classification of Hyaluronic Acid Intraarticular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence Notice Announcement 2018-12-18T05:00:00Z 2018 12 2018-12-18T05:00:00Z   2018-12-18T13:45:44Z 2018-27351 0 0 09000064839a90fa
FDA-2015-N-3454-0005 FDA FDA-2015-N-3454 Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-12-17T05:00:00Z 2018 12 2018-12-17T05:00:00Z   2024-11-12T22:52:38Z 2018-27237 1 0 090000648399ce78
FDA-2018-D-4115-0001 FDA FDA-2018-D-4115 Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-12-17T05:00:00Z 2018 12 2018-12-17T05:00:00Z 2019-02-16T04:59:59Z 2024-11-12T22:52:39Z 2018-27236 1 0 090000648399cd0c
FDA-2018-D-3984-0001 FDA FDA-2018-D-3984 Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability Notice Notice of Availability 2018-12-13T05:00:00Z 2018 12 2018-12-13T05:00:00Z   2024-11-12T22:53:26Z 2018-26957 1 0 090000648398ee6f
FDA-2018-N-4609-0001 FDA FDA-2018-N-4609 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2018-12-13T05:00:00Z 2018 12 2018-12-13T05:00:00Z   2018-12-13T14:58:17Z 2018-27043 0 0 090000648398eddc
FDA-2018-N-4416-0001 FDA FDA-2018-N-4416 Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications Notice Withdrawal 2018-12-13T05:00:00Z 2018 12 2018-12-13T05:00:00Z   2018-12-13T15:05:59Z 2018-26947 0 0 090000648398eddd
FDA-2018-P-1734-0004 FDA FDA-2018-P-1734 Determination That IC–GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2018-12-13T05:00:00Z 2018 12 2018-12-13T05:00:00Z   2018-12-13T14:47:12Z 2018-26975 0 0 090000648398ec98
FDA-2011-D-0611-0065 FDA FDA-2011-D-0611 New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-12T04:59:59Z 2019-11-18T16:51:35Z 2018-26852 0 0 0900006483987c81
FDA-2015-D-4750-0021 FDA FDA-2015-D-4750 The ‘‘Deemed to be a License’’ Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-12T04:59:59Z 2024-11-12T22:51:55Z 2018-26855 1 0 0900006483987c31
FDA-2015-D-4750-0020 FDA FDA-2015-D-4750 Interpretation of the ‘‘Deemed To Be a License’’ Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z   2018-12-12T15:17:09Z 2018-26854 0 0 0900006483987aea
FDA-2011-D-0611-0064 FDA FDA-2011-D-0611 Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z   2018-12-12T15:04:52Z 2018-26853 0 0 0900006483987c7c
FDA-2018-D-4267-0001 FDA FDA-2018-D-4267 Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-12-12T05:00:00Z 2018 12 2018-12-12T05:00:00Z 2019-02-12T04:59:59Z 2019-02-24T17:01:16Z 2018-26900 0 0 090000648398820d
FDA-2014-D-0779-0023 FDA FDA-2014-D-0779 Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z 2019-02-12T04:59:59Z 2019-08-20T19:41:28Z 2018-26724 0 0 0900006483980a94
FDA-2018-N-1990-0001 FDA FDA-2018-N-1990 Su-Chiao Kuo: Debarment Order Notice Statutory Debarment 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z   2018-12-11T14:02:34Z 2018-26778 0 0 090000648398098c
FDA-2018-N-4162-0001 FDA FDA-2018-N-4162 The Tobacco Products Scientific Advisory Committee; Notice of Meeting Notice Meeting 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z   2018-12-11T14:12:45Z 2018-26721 0 0 0900006483980a59
FDA-2018-N-4087-0001 FDA FDA-2018-N-4087 The Food and Drug Administration’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments Notice Request for Comments 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z 2019-06-22T03:59:59Z 2019-06-22T01:02:43Z 2018-26725 0 0 0900006483980af7
FDA-2018-N-1994-0001 FDA FDA-2018-N-1994 David J. Fishman: Debarment Order Notice Statutory Debarment 2018-12-11T05:00:00Z 2018 12 2018-12-11T05:00:00Z   2018-12-11T14:17:32Z 2018-26722 0 0 0900006483980a95
FDA-2018-N-4395-0001 FDA FDA-2018-N-4395 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2018-12-10T05:00:00Z 2018 12 2018-12-10T05:00:00Z 2019-02-12T04:59:59Z 2019-02-13T02:04:02Z 2018-26626 0 0 0900006483973414
FDA-2015-N-2126-0016 FDA FDA-2015-N-2126 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community Notice 30 Day Proposed Information Collection 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-01-08T04:59:59Z 2019-01-08T02:04:10Z 2018-26555 0 0 090000648395870a
FDA-2018-N-4000-0001 FDA FDA-2018-N-4000 Framework for a Real-World Evidence Program; Availability Notice Notice of Availability 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-02-06T04:59:59Z 2024-11-12T22:49:40Z 2018-26546 1 0 0900006483958758
FDA-2012-N-0961-0010 FDA FDA-2012-N-0961 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations Notice 30 Day Proposed Information Collection 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-01-08T04:59:59Z 2018-12-07T14:17:58Z 2018-26556 0 0 090000648395875c
FDA-2018-D-3380-0001 FDA FDA-2018-D-3380 Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-02-06T04:59:59Z 2024-11-12T22:49:40Z 2018-26554 1 0 090000648395867c
FDA-2018-N-3458-0001 FDA FDA-2018-N-3458 Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information Notice Announcement 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-02-06T04:59:59Z 2019-03-05T09:05:43Z 2018-26561 0 0 090000648395878b
FDA-2014-D-1814-0125 FDA FDA-2014-D-1814 Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-12-06T05:00:00Z 2018 12 2018-12-06T05:00:00Z 2019-02-05T04:59:59Z 2019-02-05T02:02:20Z 2018-26477 0 0 090000648394cd15
FDA-2017-E-3547-0006 FDA FDA-2017-E-3547 Determination of Regulatory Review Period for Purposes of Patent Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM Notice Determinations 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2018-12-04T14:30:50Z 2018-26282 0 0 0900006483939723
FDA-2017-E-3650-0006 FDA FDA-2017-E-3650 Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVA Notice Determinations 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2018-12-04T14:17:27Z 2018-26288 0 0 0900006483939066
FDA-2018-D-3632-0001 FDA FDA-2018-D-3632 Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability Notice Notice of Availability 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2024-11-12T22:50:44Z 2018-26333 1 0 09000064839394fb
FDA-2014-D-0609-0028 FDA FDA-2014-D-0609 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Notice 30 Day Proposed Information Collection 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-01-04T04:59:59Z 2019-01-05T02:02:23Z 2018-26295 0 0 090000648393964c
FDA-2015-N-3815-0004 FDA FDA-2015-N-3815 Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing Notice 60 Day Proposed Information Collection 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2019-07-23T11:55:32Z 2018-26303 0 0 090000648393907f
FDA-2017-D-5928-0007 FDA FDA-2017-D-5928 Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability Notice Notice of Availability 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z   2022-10-05T19:15:10Z 2018-26285 0 0 0900006483939624
FDA-2017-E-2801-0005 FDA FDA-2017-E-2801 Determination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSIST Notice Determinations 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2019-01-30T02:06:05Z 2018-26290 0 0 09000064839394de
FDA-2017-E-4282-0012 FDA FDA-2017-E-4282 Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE Notice Determinations 2018-12-04T05:00:00Z 2018 12 2018-12-04T05:00:00Z 2019-02-05T04:59:59Z 2019-01-30T02:05:27Z 2018-26289 0 0 09000064839390a7
FDA-2017-E-6604-0008 FDA FDA-2017-E-6604 Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA Notice Determinations 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2018-11-30T15:50:45Z 2018-26033 0 0 09000064839161bb
FDA-2018-N-4131-0001 FDA FDA-2018-N-4131 Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions Notice 60 Day Proposed Information Collection 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2019-01-30T02:09:21Z 2018-26031 0 0 0900006483915990
FDA-2013-D-1445-0065 FDA FDA-2013-D-1445 Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-03-01T04:59:59Z 2024-11-12T22:50:38Z 2018-26034 1 0 0900006483916275
FDA-2017-E-6603-0007 FDA FDA-2017-E-6603 Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA Notice Determinations 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2018-11-30T15:52:08Z 2018-26033 0 0 09000064839191b0
FDA-2018-N-4282-0001 FDA FDA-2018-N-4282 Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-17T04:59:59Z 2019-01-18T02:00:40Z 2018-25990 0 0 090000648391601c
FDA-2016-E-3305-0006 FDA FDA-2016-E-3305 Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE Notice Determinations 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2019-01-30T02:13:15Z 2018-26035 0 0 0900006483916277
FDA-2011-D-0597-0060 FDA FDA-2011-D-0597 Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring Notice 60 Day Proposed Information Collection 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-30T04:59:59Z 2022-11-22T18:59:11Z 2018-26032 0 0 0900006483915d45
FDA-2013-D-1446-0016 FDA FDA-2013-D-1446 Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-03-01T04:59:59Z 2024-11-12T22:50:38Z 2018-26028 1 0 09000064839161bc
FDA-2018-N-4227-0001 FDA FDA-2018-N-4227 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-11T04:59:59Z 2018-12-28T02:03:16Z 2018-25991 0 0 09000064839159b7
FDA-2018-N-4116-0001 FDA FDA-2018-N-4116 Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2018-11-30T05:00:00Z 2018 11 2018-11-30T05:00:00Z 2019-01-15T04:59:59Z 2019-01-11T02:01:28Z 2018-26029 0 0 090000648391572a
FDA-2007-D-0369-0456 FDA FDA-2007-D-0369 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice Notice of Availability 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-01-29T04:59:59Z 2024-11-12T22:50:12Z 2018-25950 1 0 090000648390c07a
FDA-2017-D-5625-0011 FDA FDA-2017-D-5625 Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-02-28T04:59:59Z 2024-11-12T22:50:46Z 2018-25960 1 0 090000648390c0b9
FDA-2017-D-5570-0012 FDA FDA-2017-D-5570 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-02-28T04:59:59Z 2024-11-12T22:50:46Z 2018-25959 1 0 090000648390c0fa
FDA-2018-N-4337-0001 FDA FDA-2018-N-4337 Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments Notice Request for Comments 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-04-11T03:59:59Z 2019-04-03T01:05:21Z 2018-25958 0 0 090000648390c11d
FDA-2018-N-1262-0003 FDA FDA-2018-N-1262 Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Announcement 2018-11-23T05:00:00Z 2018 11 2018-11-23T05:00:00Z   2018-11-23T20:50:10Z 2018-25480 0 0 09000064838f5b5b
FDA-2018-N-3522-4873 FDA FDA-2018-N-3522 Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period Notice Extension of Comment Period 2018-11-21T05:00:00Z 2018 11 2018-11-21T05:00:00Z 2019-01-29T04:59:59Z 2019-05-23T01:04:52Z 2018-25347 0 0 09000064838f185d
FDA-2008-N-0500-0009 FDA FDA-2008-N-0500 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Notice 30 Day Proposed Information Collection 2018-11-21T05:00:00Z 2018 11 2018-11-21T05:00:00Z 2018-12-22T04:59:59Z 2018-11-21T13:19:42Z 2018-25352 0 0 09000064838f1a72
FDA-2018-N-2027-0008 FDA FDA-2018-N-2027 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry Notice 30 Day Proposed Information Collection 2018-11-20T05:00:00Z 2018 11 2018-11-20T05:00:00Z 2018-12-21T04:59:59Z 2018-12-21T02:03:49Z 2018-25231 0 0 09000064838ec722
FDA-2018-N-3017-0001 FDA FDA-2018-N-3017 Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments Notice Request for Comments 2018-11-20T05:00:00Z 2018 11 2018-11-20T05:00:00Z 2019-04-30T03:59:59Z 2019-06-18T18:50:27Z 2018-25206 0 0 09000064838ec2c9
FDA-2012-N-0129-0013 FDA FDA-2012-N-0129 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Notice 30 Day Proposed Information Collection 2018-11-20T05:00:00Z 2018 11 2018-11-20T05:00:00Z 2018-12-21T04:59:59Z 2018-11-20T14:24:41Z 2018-25232 0 0 09000064838ec50e
FDA-2018-N-3771-0001 FDA FDA-2018-N-3771 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Notice Notice of Availability 2018-11-19T05:00:00Z 2018 11 2018-11-19T05:00:00Z   2018-11-19T14:51:02Z 2018-25128 0 0 09000064838e674f
FDA-2018-N-4142-0001 FDA FDA-2018-N-4142 Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2018-11-19T05:00:00Z 2018 11 2018-11-19T05:00:00Z   2018-11-19T14:53:26Z 2018-25187 0 0 09000064838e67e8
FDA-2018-M-2460-0002 FDA FDA-2018-M-2460 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:31:59Z 2018-25071 0 0 09000064838e0939
FDA-2017-M-6984-0002 FDA FDA-2017-M-6984 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:17:27Z 2018-25071 0 0 09000064838dffb3
FDA-2018-M-1791-0002 FDA FDA-2018-M-1791 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:28:18Z 2018-25071 0 0 09000064838e04d2
FDA-2018-M-2461-0002 FDA FDA-2018-M-2461 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:32:24Z 2018-25071 0 0 09000064838e094e
FDA-2018-M-3131-0002 FDA FDA-2018-M-3131 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:36:18Z 2018-25071 0 0 09000064838e09a3
FDA-2018-N-4002-0001 FDA FDA-2018-N-4002 Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments Notice Request for Comments 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T15:25:25Z 2018-25063 0 0 09000064838df0b4
FDA-2018-M-0792-0002 FDA FDA-2018-M-0792 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:22:03Z 2018-25071 0 0 09000064838e0376
FDA-2018-M-2883-0002 FDA FDA-2018-M-2883 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:33:59Z 2018-25071 0 0 09000064838e0952
FDA-2018-M-2983-0002 FDA FDA-2018-M-2983 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:35:53Z 2018-25071 0 0 09000064838e09a2
FDA-2018-M-2886-0002 FDA FDA-2018-M-2886 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:35:06Z 2018-25071 0 0 09000064838e09a0
FDA-2018-M-1371-0002 FDA FDA-2018-M-1371 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:22:59Z 2018-25071 0 0 09000064838e0377
FDA-2018-M-3505-0002 FDA FDA-2018-M-3505 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:37:58Z 2018-25071 0 0 09000064838e09bf
FDA-2018-M-2463-0002 FDA FDA-2018-M-2463 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:33:05Z 2018-25071 0 0 09000064838e0950
FDA-2018-M-1447-0002 FDA FDA-2018-M-1447 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:26:02Z 2018-25071 0 0 09000064838e0482
FDA-2017-M-6970-0002 FDA FDA-2017-M-6970 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:16:04Z 2018-25071 0 0 09000064838e0256
FDA-2018-M-1446-0002 FDA FDA-2018-M-1446 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:25:40Z 2018-25071 0 0 09000064838e0480
FDA-2018-M-2118-0002 FDA FDA-2018-M-2118 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:29:42Z 2018-25071 0 0 09000064838e04d5
FDA-2018-M-2885-0002 FDA FDA-2018-M-2885 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:34:42Z 2018-25071 0 0 09000064838e0954
FDA-2018-M-2884-0002 FDA FDA-2018-M-2884 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:34:21Z 2018-25071 0 0 09000064838e0953
FDA-2018-M-0620-0002 FDA FDA-2018-M-0620 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:20:19Z 2018-25071 0 0 09000064838e0370
FDA-2018-M-1237-0002 FDA FDA-2018-M-1237 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Publication 2018-11-16T05:00:00Z 2018 11 2018-11-16T05:00:00Z   2018-11-16T16:24:17Z 2018-25071 0 0 09000064838e047e

Next page

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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);