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withdrawn,object_id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-D-6564-0001,FDA,FDA-2017-D-6564,"Best Practices for Communication Between Investigational New Drug
Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability",Notice,Notice of Availability,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,,2017-12-29T14:28:34Z,2017-28139,0,0,0900006482d832c0
FDA-2017-D-6530-0001,FDA,FDA-2017-D-6530,Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-29T05:00:00Z,2017,12,2017-12-29T05:00:00Z,2018-03-30T03:59:59Z,2018-03-28T01:02:41Z,2017-28140,0,0,0900006482d832bd
FDA-2001-N-0437-0004,FDA,FDA-2001-N-0437,Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,Notice of Approval,2017-12-28T05:00:00Z,2017,12,,,2024-11-25T16:30:52Z,01–25763,0,0,09000064804e8894
FDA-2017-N-6778-0001,FDA,FDA-2017-N-6778,"Fostering Medical Innovation: Case for Quality Voluntary Medical Device
Manufacturing and Product Quality Pilot Program",Notice,Announcement,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T14:57:25Z,2017-28044,0,0,0900006482d7a81e
FDA-2001-N-0437-0002,FDA,FDA-2001-N-0437,Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,30 Day Proposed Information Collection,2017-12-28T05:00:00Z,2017,12,2001-06-15T04:00:00Z,2001-07-17T03:59:59Z,2024-11-25T16:25:48Z,01-15081,0,0,09000064804e8892
FDA-2017-N-6888-0001,FDA,FDA-2017-N-6888,"Neurological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting",Notice,Meeting,2017-12-28T05:00:00Z,2017,12,2017-12-28T05:00:00Z,,2017-12-28T15:06:19Z,2017-27974,0,0,0900006482d7a869
FDA-2001-N-0437-0001,FDA,FDA-2001-N-0437,Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds,Notice,60 Day Proposed Information Collection,2017-12-28T05:00:00Z,2017,12,2001-02-09T05:00:00Z,2001-04-11T03:59:59Z,2024-11-25T16:21:13Z,01-3416,0,0,09000064804e8891
FDA-2017-D-6784-0001,FDA,FDA-2017-D-6784,Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-27T05:00:00Z,2017,12,2017-12-27T05:00:00Z,2018-03-28T03:59:59Z,2018-03-29T01:05:21Z,2017-28043,0,0,0900006482d76311
FDA-2015-E-2655-0006,FDA,FDA-2015-E-2655,Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA,Notice,Determinations,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2017-12-26T16:01:36Z,2017-27745,0,0,0900006482d72685
FDA-2015-E-2597-0007,FDA,FDA-2015-E-2597,Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO,Notice,Determinations,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2024-02-27T14:24:20Z,2017-27684,0,0,0900006482d727c1
FDA-2014-N-2294-0005,FDA,FDA-2014-N-2294,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the 
Food and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign",Notice,60 Day Proposed Information Collection,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2018-03-15T16:37:13Z,2017-27712,0,0,0900006482d72988
FDA-2015-D-1245-0019,FDA,FDA-2015-D-1245,Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,,2017-12-26T16:51:11Z,2017-27786,0,0,0900006482d727c5
FDA-2015-E-2582-0007,FDA,FDA-2015-E-2582,Determination of Regulatory Review Period for Purposes of Patent Extension; STRIVERDI RESPIMAT,Notice,Determinations,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2017-12-26T16:25:50Z,2017-27710,0,0,0900006482d727f7
FDA-2014-N-1069-0004,FDA,FDA-2014-N-1069,"Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830",Notice,60 Day Proposed Information Collection,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2017-12-26T16:35:03Z,2017-27757,0,0,0900006482d728a4
FDA-2015-E-2656-0006,FDA,FDA-2015-E-2656,Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA,Notice,Determinations,2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2017-12-26T16:07:16Z,2017-27745,0,0,0900006482d732f2
FDA-2012-D-0307-0010,FDA,FDA-2012-D-0307,Amendment to ‘‘Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;’’ Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-22T05:00:00Z,2017,12,2017-12-22T05:00:00Z,2018-03-23T03:59:59Z,2018-01-06T02:01:16Z,2017-27569,0,0,0900006482d56ac6
FDA-1995-D-0288-0002,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Draft Guidance for Industry;
Availability",Notice,Notice of Availability,2017-12-22T05:00:00Z,2017,12,2017-12-22T05:00:00Z,2018-03-23T03:59:59Z,2018-03-23T13:00:58Z,2017-27589,0,0,0900006482d56bc8
FDA-2017-N-6395-0001,FDA,FDA-2017-N-6395,Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient  Engagement Collaborative,Notice,Request for Nominations,2017-12-22T05:00:00Z,2017,12,2017-12-22T05:00:00Z,,2017-12-22T14:08:24Z,2017-27538,0,0,0900006482d56c24
FDA-2017-N-1277-0001,FDA,FDA-2017-N-1277,Debarment Orders: Keith J. Pierce,Notice,Notice of Action Taken,2017-12-21T05:00:00Z,2017,12,2017-12-21T05:00:00Z,,2017-12-21T14:54:02Z,2017-27485,0,0,0900006482d48cd1
FDA-2017-D-6380-0001,FDA,FDA-2017-D-6380,"Clarification of Orphan Designation of Drugs and Biologics for Pediatric
Subpopulations of Common Diseases; Draft Guidance for Industry;
Availability",Notice,Notice of Availability,2017-12-20T05:00:00Z,2017,12,2017-12-20T05:00:00Z,2018-01-20T04:59:59Z,2018-01-20T02:02:49Z,2017-27435,0,0,0900006482d3f50b
FDA-2017-D-6580-0001,FDA,FDA-2017-D-6580,"Drug Products Labeled as Homeopathic; Draft Guidance for Food
and Drug Administration Staff and Industry; Availability",Notice,Notice of Availability,2017-12-20T05:00:00Z,2017,12,2017-12-20T05:00:00Z,2018-03-21T03:59:59Z,2018-03-21T13:00:23Z,2017-27157,0,0,0900006482d3e121
FDA-2011-N-0075-0006,FDA,FDA-2011-N-0075,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory 
Practice Regulations for Nonclinical Studies",Notice,30 Day Proposed Information Collection,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2018-01-19T04:59:59Z,2017-12-19T15:36:36Z,2017-27255,0,0,0900006482d3ab7d
FDA-2017-N-6716-0001,FDA,FDA-2017-N-6716,New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop; Request for Comments,Notice,Announcement,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2018-02-15T04:59:59Z,2018-02-15T02:03:48Z,2017-27279,0,0,0900006482d3ae6f
FDA-2017-N-4678-0001,FDA,FDA-2017-N-4678,Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability,Notice,Announcement,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2020-12-31T04:59:59Z,2021-01-01T02:01:53Z,2017-27246,0,0,0900006482d3ab2c
FDA-2011-N-0672-0006,FDA,FDA-2011-N-0672,Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices,Notice,60 Day Proposed Information Collection,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2018-02-21T04:59:59Z,2018-03-13T15:58:17Z,2017-27276,0,0,0900006482d3aebe
FDA-2017-D-6535-0001,FDA,FDA-2017-D-6535,"Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability",Notice,Notice of Availability,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2018-03-20T03:59:59Z,2018-03-20T01:03:43Z,2017-27275,0,0,0900006482d3ac76
FDA-2017-N-6356-0001,FDA,FDA-2017-N-6356,"Investigational In Vitro Diagnostics Used in Clinical Investigations of
Therapeutic Products; Draft Guidance for Industry, Food and Drug
Administration Staff, Sponsors, and Institutional Review Boards;  Availability",Notice,Notice of Availability,2017-12-18T05:00:00Z,2017,12,2017-12-18T05:00:00Z,2018-03-20T03:59:59Z,2018-03-20T13:01:12Z,2017-27155,0,0,0900006482d30343
FDA-2017-D-0759-0001,FDA,FDA-2017-D-0759,"Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2017-12-18T05:00:00Z,2017,12,2017-12-18T05:00:00Z,2018-03-20T03:59:59Z,2018-03-20T01:02:36Z,2017-27133,0,0,0900006482d2f9b8
FDA-2017-D-6765-0001,FDA,FDA-2017-D-6765,Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2017-12-18T05:00:00Z,2017,12,2017-12-18T05:00:00Z,2018-03-20T03:59:59Z,2018-03-21T01:01:16Z,2017-27132,0,0,0900006482d30212
FDA-2017-D-6752-0001,FDA,FDA-2017-D-6752,Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-18T05:00:00Z,2017,12,2017-12-18T05:00:00Z,2018-02-17T04:59:59Z,2018-02-17T02:02:50Z,2017-27124,0,0,0900006482d30211
FDA-2017-D-6617-0001,FDA,FDA-2017-D-6617,"Developing Targeted Therapies in Low-Frequency Molecular Subsets of a
Disease; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2017-12-18T05:00:00Z,2017,12,2017-12-18T05:00:00Z,2018-02-17T04:59:59Z,2018-02-17T02:01:16Z,2017-27156,0,0,0900006482d3028d
FDA-2017-D-6702-0001,FDA,FDA-2017-D-6702,The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2017-12-15T05:00:00Z,2017,12,2017-12-15T05:00:00Z,2018-02-14T04:59:59Z,2018-01-24T02:04:12Z,2017-26987,0,0,0900006482d1290f
FDA-2017-N-0809-0005,FDA,FDA-2017-N-0809,Issuance of Priority Review Voucher; Rare Pediatric Disease Product,Notice,Announcement,2017-12-15T05:00:00Z,2017,12,2017-12-15T05:00:00Z,,2017-12-15T15:25:40Z,2017-27049,0,0,0900006482d126f3
FDA-2011-N-0362-0008,FDA,FDA-2011-N-0362,Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals,Notice,60 Day Proposed Information Collection,2017-12-14T05:00:00Z,2017,12,2017-12-14T05:00:00Z,2018-02-13T04:59:59Z,2017-12-14T17:26:03Z,2017-26932,0,0,0900006482d08dcb
FDA-2015-D-4562-0024,FDA,FDA-2015-D-4562,Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction,Notice,Correction,2017-12-14T05:00:00Z,2017,12,2017-12-14T05:00:00Z,,2017-12-14T17:33:45Z,2017-26938,0,0,0900006482d08e78
FDA-2017-N-6312-0001,FDA,FDA-2017-N-6312,Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments,Notice,Request for Comments,2017-12-14T05:00:00Z,2017,12,2017-12-14T05:00:00Z,2018-05-19T03:59:59Z,2018-04-10T01:05:05Z,2017-26978,0,0,0900006482d08e7c
FDA-2011-N-0279-0007,FDA,FDA-2011-N-0279,"Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative  Procedures, Policies, and Requirements",Notice,60 Day Proposed Information Collection,2017-12-14T05:00:00Z,2017,12,2017-12-14T05:00:00Z,2018-02-13T04:59:59Z,2017-12-14T17:20:49Z,2017-26933,0,0,0900006482d084dd
FDA-2017-N-5925-0011,FDA,FDA-2017-N-5925,21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website,Notice,Announcement,2017-12-13T05:00:00Z,2017,12,2017-12-13T05:00:00Z,,2017-12-13T17:37:08Z,2017-26790,0,0,0900006482d01f46
FDA-2017-N-6455-0001,FDA,FDA-2017-N-6455,Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,Notice,60 Day Proposed Information Collection,2017-12-13T05:00:00Z,2017,12,2017-12-13T05:00:00Z,2018-02-13T04:59:59Z,2018-02-13T02:05:45Z,2017-26794,0,0,0900006482d01f45
FDA-2017-D-6352-0001,FDA,FDA-2017-D-6352,Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability,Notice,Guidance,2017-12-13T05:00:00Z,2017,12,2017-12-13T05:00:00Z,2018-02-13T04:59:59Z,2018-02-13T14:00:38Z,2017-26828,0,0,0900006482d01f79
FDA-2017-D-6554-0001,FDA,FDA-2017-D-6554,Guidance: Refuse to File-New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research,Notice,Guidance,2017-12-13T05:00:00Z,2017,12,2017-12-13T05:00:00Z,2018-02-13T04:59:59Z,2017-12-13T14:40:07Z,2017-26791,0,0,0900006482d01c53
FDA-2014-N-0345-0007,FDA,FDA-2014-N-0345,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Data To Support
Drug Product Communications as Used by the Food and Drug
Administration",Notice,30 Day Proposed Information Collection,2017-12-13T05:00:00Z,2017,12,2017-12-13T05:00:00Z,2018-01-13T04:59:59Z,2017-12-13T17:25:59Z,2017-26795,0,0,0900006482d01f42
FDA-2014-N-1030-0005,FDA,FDA-2014-N-1030,Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting,Notice,60 Day Proposed Information Collection,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-02-13T04:59:59Z,2017-12-31T02:00:22Z,2017-26690,0,0,0900006482cfd0a6
FDA-2012-N-1021-0038,FDA,FDA-2012-N-1021,Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development,Notice,Announcement,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-02-13T04:59:59Z,2018-02-13T02:02:29Z,2017-26721,0,0,0900006482cfd636
FDA-1999-D-4079-0008,FDA,FDA-1999-D-4079,"Product Name Placement, Size, and Prominence in Promotional Labeling
and Advertisements; Guidance for Industry; Availability",Notice,Notice of Availability,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,,2017-12-12T18:36:42Z,2017-26725,0,0,0900006482cfd500
FDA-2017-D-6528-0001,FDA,FDA-2017-D-6528,Refusal of Inspection by a Foreign Food Establishment or Foreign  Government; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-02-27T04:59:59Z,2018-02-27T14:01:46Z,2017-26692,0,0,0900006482cfd503
FDA-2017-N-6397-0001,FDA,FDA-2017-N-6397,Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines,Notice,60 Day Proposed Information Collection,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-02-13T04:59:59Z,2018-02-13T02:01:56Z,2017-26672,0,0,0900006482cfd54e
FDA-2016-N-4487-0017,FDA,FDA-2016-N-4487,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Consumer and
Healthcare Professional Identification of and Responses to Deceptive
Prescription Drug Promotion",Notice,30 Day Proposed Information Collection,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-01-12T04:59:59Z,2017-12-12T18:09:19Z,2017-26704,0,0,0900006482cfd550
FDA-2011-N-0015-0005,FDA,FDA-2011-N-0015,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Orphan Products
Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/
Food and Drug Administration Form for Orphan Medicinal Product
Designation",Notice,30 Day Proposed Information Collection,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-01-12T04:59:59Z,2017-12-12T17:22:33Z,2017-26669,0,0,0900006482cfd0ff
FDA-2013-N-0523-0007,FDA,FDA-2013-N-0523,"Agency Information Collection Activities: Submission for Office of
Management and Budget Review; Comment Request; Applications for
Food and Drug Administration Approval To Market a New Drug",Notice,30 Day Proposed Information Collection,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,2018-01-12T04:59:59Z,2018-01-11T14:01:28Z,2017-26670,0,0,0900006482cfce02
FDA-2017-P-2659-0006,FDA,FDA-2017-P-2659,"Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2017-12-12T05:00:00Z,2017,12,2017-12-12T05:00:00Z,,2017-12-12T18:27:25Z,2017-26693,0,0,0900006482cfd5ec
FDA-2014-N-1072-0005,FDA,FDA-2014-N-1072,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for 
Participation in Food and Drug Administration Fellowship Programs",Notice,30 Day Proposed Information Collection,2017-12-11T05:00:00Z,2017,12,2017-12-11T05:00:00Z,2018-01-11T04:59:59Z,2017-12-11T14:46:21Z,2017-26543,0,0,0900006482cf739c
FDA-2009-D-0508-0017,FDA,FDA-2009-D-0508,"Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments; Guidance for Industry; Availability",Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,,2017-12-08T15:42:30Z,2017-26469,0,0,0900006482cf29f2
FDA-2017-D-6569-0001,FDA,FDA-2017-D-6569,Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,2018-03-16T03:59:59Z,2019-10-23T14:25:18Z,2017-26439,0,0,0900006482cf2a39
FDA-2016-N-3083-0003,FDA,FDA-2016-N-3083,"Report on the Performance of Drug and Biologics Firms in Conducting
Postmarketing Requirements and Commitments; Availability",Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,,2017-12-08T17:36:17Z,2017-26470,0,0,0900006482cf2abe
FDA-2017-D-5767-0021,FDA,FDA-2017-D-5767,"Abbreviated New Drug Applications for Certain Highly Purified Synthetic
Peptide Drug Products That Refer to Listed Drugs of Recombinant
Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability;
Extension of Comment Period",Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,2018-02-05T04:59:59Z,2018-02-03T02:04:56Z,2017-26436,0,0,0900006482cf2a7a
FDA-2016-D-2483-0019,FDA,FDA-2016-D-2483,"Software as a Medical Device: Clinical Evaluation; International Medical
Device Regulators Forum; Guidance for Industry and Food and Drug
Administration Staff; Availability",Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,,2017-12-08T16:20:53Z,2017-26441,0,0,0900006482cf2ac2
FDA-2017-N-6607-0001,FDA,FDA-2017-N-6607,Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments,Notice,Request for Comments,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,2018-04-17T03:59:59Z,2018-04-18T01:01:57Z,2017-26440,0,0,0900006482cf291f
FDA-2017-D-6294-0001,FDA,FDA-2017-D-6294,Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,2018-02-07T04:59:59Z,2018-02-07T14:00:56Z,2017-26442,0,0,0900006482cf29f1
FDA-2017-N-4301-0020,FDA,FDA-2017-N-4301,Fostering Digital Health Innovation: Developing the Software  Precertification Program; Public Workshop; Request for Comments,Notice,Request for Comments,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,,2024-11-07T01:13:10Z,2017-26457,1,0,0900006482cf2ac1
FDA-2017-N-6313-0001,FDA,FDA-2017-N-6313,"Prescription Drug User Fee Act VI Commitment To Assess Current  Practices of the Food and Drug Administration and Sponsors in
Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments",Notice,Request for Comments,2017-12-08T05:00:00Z,2017,12,2017-12-08T05:00:00Z,2018-01-23T04:59:59Z,2018-01-23T02:02:52Z,2017-26437,0,0,0900006482cf28d9
FDA-2013-N-1161-0007,FDA,FDA-2013-N-1161,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey,Notice,30 Day Proposed Information Collection,2017-12-07T05:00:00Z,2017,12,2017-12-07T05:00:00Z,2018-01-09T04:59:59Z,2018-01-09T02:02:16Z,2017-26356,0,0,0900006482ced75a
FDA-2017-N-6476-0001,FDA,FDA-2017-N-6476,Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-07T05:00:00Z,2017,12,2017-12-07T05:00:00Z,2018-02-06T04:59:59Z,2018-02-06T02:04:23Z,2017-26357,0,0,0900006482ced510
FDA-2009-D-0137-0045,FDA,FDA-2009-D-0137,Use of Serological Tests to Reduce the Risk of Transmission of  Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability,Notice,Notice of Availability,2017-12-06T05:00:00Z,2017,12,2017-12-06T05:00:00Z,,2017-12-06T15:20:12Z,2017-26226,0,0,0900006482ce90a2
FDA-2016-D-1159-0006,FDA,FDA-2016-D-1159,"Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid
Services With Coverage Decisions; Guidance for Sponsors, Clinical
Investigators, Industry, Institutional Review Boards, and Food and Drug
Administration Staff; Availability",Notice,Notice of Availability,2017-12-05T05:00:00Z,2017,12,2017-12-05T05:00:00Z,,2017-12-05T17:07:32Z,2017-26195,0,0,0900006482cdbd97
FDA-2016-D-1210-0031,FDA,FDA-2016-D-1210,"Technical Considerations for Additive Manufactured Medical Devices;
Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2017-12-05T05:00:00Z,2017,12,2017-12-05T05:00:00Z,,2017-12-05T17:11:51Z,2017-26196,0,0,0900006482cdbdfb
FDA-2014-N-0192-0010,FDA,FDA-2014-N-0192,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Establishing and
Maintaining Lists of United States Manufacturers/Processors With
Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China",Notice,30 Day Proposed Information Collection,2017-12-04T05:00:00Z,2017,12,2017-12-04T05:00:00Z,2018-01-04T04:59:59Z,2017-12-04T15:41:41Z,2017-26042,0,0,0900006482cd3ca9
FDA-2017-N-4853-0002,FDA,FDA-2017-N-4853,Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant,Notice,General Notice,2017-12-04T05:00:00Z,2017,12,2017-12-04T05:00:00Z,,2017-12-04T15:24:30Z,2017-26013,0,0,0900006482cd3be6
FDA-2017-N-6475-0001,FDA,FDA-2017-N-6475,"Food and Drug Administration Fiscal Year 2017 Performance Review Board
Members",Notice,Announcement,2017-12-04T05:00:00Z,2017,12,2017-12-04T05:00:00Z,,2017-12-04T15:53:13Z,2017-26015,0,0,0900006482cd4273
FDA-2017-N-6286-0001,FDA,FDA-2017-N-6286,"Site Visit Training Program for Office of Pharmaceutical Quality Staff;
Information Available to Industry",Notice,Announcement,2017-12-04T05:00:00Z,2017,12,2017-12-04T05:00:00Z,2018-02-03T04:59:59Z,2018-01-31T02:00:58Z,2017-26055,0,0,0900006482cd3b8e
FDA-2004-N-0451-0042,FDA,FDA-2004-N-0451,"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048",Notice,Announcement,2017-12-04T05:00:00Z,2017,12,2017-12-04T05:00:00Z,,2024-11-07T01:13:33Z,2017-26043,1,0,0900006482cd3cde
FDA-2017-N-6591-0001,FDA,FDA-2017-N-6591,"Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications",Notice,Withdrawal,2017-12-01T05:00:00Z,2017,12,2017-12-01T05:00:00Z,,2017-12-04T15:00:20Z,2017-25920,0,0,0900006482cc9bb9
FDA-2017-N-6293-0001,FDA,FDA-2017-N-6293,Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,Notice,Request for Comments,2017-12-01T05:00:00Z,2017,12,2017-12-01T05:00:00Z,2018-01-11T04:59:59Z,2018-01-10T02:01:11Z,2017-25911,0,0,0900006482cc9c36
FDA-2017-P-4027-0004,FDA,FDA-2017-P-4027,"Determination That METICORTEN (Prednisone) Tablets, 1 Milligram and 5
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness",Notice,Determinations,2017-12-01T05:00:00Z,2017,12,2017-12-01T05:00:00Z,,2017-12-04T14:55:48Z,2017-25900,0,0,0900006482cc9ac1
FDA-1996-N-0473-0002,FDA,FDA-1996-N-0473,Gary D. Mays; Debarment Order,Notice,Notice of Final Rule,2017-11-30T05:00:00Z,2017,11,,,2017-11-30T14:55:57Z,97-1784,0,0,0900006480507b6b
FDA-2015-E-3316-0006,FDA,FDA-2015-E-3316,Determination of Regulatory Review Periods for Purposes of Patent Extension: ADVANTAME,Notice,Determinations,2017-11-30T05:00:00Z,2017,11,2017-11-30T05:00:00Z,2018-01-30T04:59:59Z,2017-11-30T15:57:22Z,2017-25780,0,0,0900006482cc09cd
FDA-2015-E-3316-0007,FDA,FDA-2015-E-3316,Determination of Regulatory Review Periods for Purposes of Patent Extension: ADVANTAME,Notice,Determinations,2017-11-30T05:00:00Z,2017,11,2017-11-30T05:00:00Z,2018-01-30T04:59:59Z,2017-11-30T15:59:10Z,2017-25780,0,0,0900006482cc2a5c
FDA-2017-D-5570-0001,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,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2018-01-14T03:27:08Z,2017-25775,0,0,0900006482cbbc77
FDA-2016-E-2181-0005,FDA,FDA-2016-E-2181,"Determination of Regulatory Review Period for Purposes of Patent
Extension; XURIDEN",Notice,Determinations,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2017-11-29T16:32:21Z,2017-25770,0,0,0900006482cbbcc8
FDA-2016-E-2216-0005,FDA,FDA-2016-E-2216,"Determination of Regulatory Review Period for Purposes of Patent
Extension; VELTASSA",Notice,Determinations,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2017-11-29T16:39:29Z,2017-25761,0,0,0900006482cbbd77
FDA-2009-N-0505-0011,FDA,FDA-2009-N-0505,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Recordkeeping
and Reporting Requirements for Human Food and Cosmetics  Manufactured From, Processed With, or Otherwise Containing Material From Cattle",Notice,30 Day Proposed Information Collection,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2017-12-30T04:59:59Z,2017-11-30T02:03:20Z,2017-25767,0,0,0900006482cbbc73
FDA-2016-E-1292-0005,FDA,FDA-2016-E-1292,"Determination of Regulatory Review Period for Purposes of Patent
Extension; REXULTI",Notice,Determinations,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2017-11-29T16:37:58Z,2017-25772,0,0,0900006482cbbd2a
FDA-2014-E-1653-0006,FDA,FDA-2014-E-1653,"Determination of Regulatory Review Period for Purposes of Patent
Extension; SOLX SYSTEM",Notice,Determinations,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2017-11-29T16:36:24Z,2017-25773,0,0,0900006482cbbd25
FDA-2017-N-6373-0001,FDA,FDA-2017-N-6373,"Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams",Notice,Withdrawal,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,,2017-11-29T16:30:15Z,2017-25771,0,0,0900006482cbbc78
FDA-2017-D-5625-0001,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,2017-11-29T05:00:00Z,2017,11,2017-11-29T05:00:00Z,2018-01-30T04:59:59Z,2018-01-14T03:27:10Z,2017-25774,0,0,0900006482cbbd24
FDA-2016-E-0534-0006,FDA,FDA-2016-E-0534,"Determination of Regulatory Review Period for Purposes of Patent
Extension; RAPIVAB",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T16:07:01Z,2017-25676,0,0,0900006482cb6df7
FDA-2016-E-2374-0005,FDA,FDA-2016-E-2374,Determination of Regulatory Review Period for Purposes of Patent  Extension; YONDELIS,Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T15:55:11Z,2017-25683,0,0,0900006482cb669e
FDA-2016-E-1195-0005,FDA,FDA-2016-E-1195,"Determination of Regulatory Review Period for Purposes of Patent
Extension; Senza Spinal Cord Stimulation System",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T15:51:38Z,2017-25684,0,0,0900006482cb77b4
FDA-2016-E-0533-0006,FDA,FDA-2016-E-0533,"Determination of Regulatory Review Period for Purposes of Patent
Extension; RAPIVAB",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T16:07:34Z,2017-25676,0,0,0900006482cb8369
FDA-2012-D-0384-0021,FDA,FDA-2012-D-0384,Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,,2017-11-28T16:13:29Z,2017-25632,0,0,0900006482cb661a
FDA-2016-E-1237-0005,FDA,FDA-2016-E-1237,"Determination of Regulatory Review Period for Purposes of Patent
Extension; SAVAYSA",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T15:56:38Z,2017-25703,0,0,0900006482cb67b4
FDA-2016-E-1534-0004,FDA,FDA-2016-E-1534,"Determination of Regulatory Review Period for Purposes of Patent
Extension; Senza Spinal Cord Stimulation System",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T15:51:03Z,2017-25684,0,0,0900006482cb661f
FDA-2016-E-0623-0005,FDA,FDA-2016-E-0623,"Determination of Regulatory Review Period for Purposes of Patent
Extension; ZERBAXA",Notice,Determinations,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,2018-01-30T04:59:59Z,2017-11-28T16:04:50Z,2017-25682,0,0,0900006482cb6dc0
FDA-2017-N-0001-0042,FDA,FDA-2017-N-0001,"Weighing the Evidence: Variant Classification and Interpretation in
Precision Oncology; Public Workshop",Notice,Public Meetings,2017-11-28T05:00:00Z,2017,11,2017-11-28T05:00:00Z,,2017-11-28T16:02:06Z,2017-25584,0,0,0900006482cb67bb
FDA-2010-N-0161-0007,FDA,FDA-2010-N-0161,"Agency Information Collection Activities; Proposed Collection; 
Comment Request; Export of Food and Drug Administration-Regulated 
Products: Export Certificates",Notice,60 Day Proposed Information Collection,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,2018-01-27T04:59:59Z,2018-01-27T14:01:26Z,2017-25456,0,0,0900006482cae34e
FDA-2010-N-0601-0006,FDA,FDA-2010-N-0601,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,,2017-11-27T13:36:40Z,2017-25452,0,0,0900006482cae3f1
FDA-2016-N-2496-0005,FDA,FDA-2016-N-2496,"Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Import Trade
Auxiliary Communication System",Notice,30 Day Proposed Information Collection,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,2017-06-27T03:59:59Z,2017-11-27T13:49:24Z,2017-10817,0,0,09000064826392b7
FDA-2015-D-4562-0022,FDA,FDA-2015-D-4562,Meetings: Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop,Notice,Announcement,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,,2017-11-27T14:49:30Z,2017-25454,0,0,0900006482cae426
FDA-2007-N-0037-0009,FDA,FDA-2007-N-0037,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,,2025-07-23T16:34:04Z,2017-25452,0,0,0900006482cae6fa
FDA-2017-D-6526-0001,FDA,FDA-2017-D-6526,Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2017-11-27T05:00:00Z,2017,11,2017-11-27T05:00:00Z,2018-01-27T04:59:59Z,2018-01-27T02:01:47Z,2017-25457,0,0,0900006482cae5c8