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withdrawn,object_id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FDA-2007-D-0369-0459,FDA,FDA-2007-D-0369,"Product-Specific Guidance for Linaclotide; Draft Guidance for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