documents
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
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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| FDA-2007-D-0369-0459 | FDA | None FDA-2007-D-0369 | Product-Specific Guidance for Linaclotide; Draft Guidance for Industry | Notice | Notice of Availability | 2018-12-28T05:00:00Z | 2018 | 12 | 2018-12-28T05:00:00Z | 2019-02-27T04:59:59Z | 2019-02-27T02:04:39Z |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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