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

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969 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2017 sorted by posted_date descending

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  • 2017 · 969 ✖

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  • Notice · 969 ✖

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  • FDA · 969 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-03-30T03:59:59Z 2018-03-28T01:02:41Z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 CGMP Regulations for Medicated Feeds-Closed 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 CGMP Regulations for Medicated Feeds-Closed 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 CGMP Regulations for Medicated Feeds-Closed 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 Changes to be Reported for Product and Establishment License Application; Guidance 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 Product Name Placement,Size, & Prominence in Advertising 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 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards 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 Debarment of Gary D. Mays; Notice of Opportunity for Hearing 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

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