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

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869 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2015 sorted by posted_date descending

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posted_year 1

  • 2015 · 869 ✖

document_type 1

  • Notice · 869 ✖

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  • FDA · 869 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-D-4803-0001 FDA FDA-2015-D-4803 Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals''); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z 2016-03-01T04:59:59Z 2016-02-26T23:00:43Z 2015-32920 0 0 0900006481dde96a
FDA-2010-D-0434-0028 FDA FDA-2010-D-0434 Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance Notice Withdrawal 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T14:04:06Z 2015-32781 0 0 0900006481ddb9fb
FDA-2007-D-0369-0370 FDA FDA-2007-D-0369 Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-02-29T22:00:18Z 2015-32723 0 0 0900006481dd74ac
FDA-2015-N-4170-0001 FDA FDA-2015-N-4170 Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases Notice General Notice 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-01-29T04:59:59Z 2016-01-29T22:01:07Z 2015-32724 0 0 0900006481dd7a8b
FDA-2013-N-0242-0005 FDA FDA-2013-N-0242 Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice 60 Day Proposed Information Collection 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-02-29T22:00:25Z 2015-32685 0 0 0900006481dd7930
FDA-2012-N-1021-0016 FDA FDA-2012-N-1021 Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development Notice Announcement 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-04-29T16:00:21Z 2015-32726 0 0 0900006481dd79c0
FDA-2014-D-1318-0001 FDA FDA-2014-D-1318 Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability Notice Notice of Availability 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-29T03:59:59Z 2016-03-29T04:00:44Z 2015-32591 0 0 0900006481dd7b15
FDA-2013-E-1692-0006 FDA FDA-2013-E-1692 Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA Notice Determinations 2015-12-28T05:00:00Z 2015 12 2015-12-28T05:00:00Z 2016-02-27T04:59:59Z 2015-12-28T14:36:14Z 2015-32475 0 0 0900006481dd3c17
FDA-2013-E-1691-0006 FDA FDA-2013-E-1691 Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA Notice Determinations 2015-12-28T05:00:00Z 2015 12 2015-12-28T05:00:00Z 2016-02-27T04:59:59Z 2015-12-28T19:47:01Z 2015-32475 0 0 0900006481dd3e06
FDA-2015-P-1898-0003 FDA FDA-2015-P-1898 Determination That KYTRIL Granisetron Hydrochloride) Tablets, Equivalent 1 Milligram and 2 Milligram Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-12-28T05:00:00Z 2015 12 2015-12-28T05:00:00Z   2015-12-28T14:45:44Z 2015-32496 0 0 0900006481dd3cba
FDA-2015-N-0001-0114 FDA FDA-2015-N-0001 Externally-Led Patient-Focused Drug Development Meetings Notice Meeting 2015-12-28T05:00:00Z 2015 12 2015-12-28T05:00:00Z   2015-12-28T19:43:09Z 2015-32476 0 0 0900006481dd3b75
FDA-2015-D-4386-0001 FDA FDA-2015-D-4386 Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-24T05:00:00Z 2015 12 2015-12-24T05:00:00Z 2016-03-24T03:59:59Z 2016-03-22T18:00:26Z 2015-32323 0 0 0900006481dd00d7
FDA-2015-N-2163-0004 FDA FDA-2015-N-2163 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements Notice 30 Day Proposed Information Collection 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-01-23T04:59:59Z 2015-12-23T14:41:50Z 2015-32251 0 0 0900006481dc96ef
FDA-2015-D-4644-0001 FDA FDA-2015-D-4644 Draft Guidance for Industry on Advancement of Emerging Technology Applications To Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-02-23T04:59:59Z 2016-02-22T23:00:11Z 2015-32316 0 0 0900006481dc96eb
FDA-2012-N-0873-0004 FDA FDA-2012-N-0873 Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products; Correction Notice Correction 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z   2015-12-23T15:02:59Z 2015-32252 0 0 0900006481dc9731
FDA-2013-E-1433-0004 FDA FDA-2013-E-1433 Determination of Regulatory Review Period for Purposes of Patent Extension: JETREA, Notice Determinations 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-02-23T04:59:59Z 2015-12-23T14:57:05Z 2015-32247 0 0 0900006481dc9730
FDA-2013-E-1437-0004 FDA FDA-2013-E-1437 Determination of Regulatory Review Period for Purposes of Patent Extension: JETREA, Notice Determinations 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-02-23T04:59:59Z 2015-12-23T17:26:13Z 2015-32247 0 0 0900006481dcaddd
FDA-2013-E-1435-0004 FDA FDA-2013-E-1435 Determination of Regulatory Review Period for Purposes of Patent Extension: JETREA, Notice Determinations 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-02-23T04:59:59Z 2015-12-23T17:24:27Z 2015-32247 0 0 0900006481dcaddc
FDA-2012-N-0976-0004 FDA FDA-2012-N-0976 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products Notice 60 Day Proposed Information Collection 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-02-23T04:59:59Z 2016-03-04T13:03:35Z 2015-32253 0 0 0900006481dc98b8
FDA-2015-D-1211-0098 FDA FDA-2015-D-1211 Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability, Notice Notice of Availability 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z   2023-02-28T14:29:06Z 2015-32250 0 0 0900006481dca583
FDA-2015-N-0001-0113 FDA FDA-2015-N-0001 Allergenic Products Advisory Committee; Notice of Meeting Notice Meeting 2015-12-21T05:00:00Z 2015 12 2015-12-21T05:00:00Z   2015-12-21T14:45:50Z 2015-31894 0 0 0900006481dbddb1
FDA-2015-N-0001-0112 FDA FDA-2015-N-0001 Risk Communication Advisory Committee; Notice of Meeting Notice Meeting 2015-12-21T05:00:00Z 2015 12 2015-12-21T05:00:00Z   2015-12-21T14:43:29Z 2015-31893 0 0 0900006481dbdd6f
FDA-2015-N-0001-0111 FDA FDA-2015-N-0001 Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting Notice Meeting 2015-12-18T05:00:00Z 2015 12 2015-12-18T05:00:00Z   2015-12-18T14:39:06Z 2015-31825 0 0 0900006481db9853
FDA-2013-E-0474-0004 FDA FDA-2013-E-0474 Determination of Regulatory Review Period for Purposes of Patent Extension; XTANDI Notice Determinations 2015-12-18T05:00:00Z 2015 12 2015-12-18T05:00:00Z 2016-02-17T04:59:59Z 2015-12-18T14:43:32Z 2015-31824 0 0 0900006481db9890
FDA-2015-N-4667-0001 FDA FDA-2015-N-4667 Determination That Vancomycin Hydrochloride Injection Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z   2015-12-17T15:25:02Z 2015-31689 0 0 0900006481db6c06
FDA-2011-D-0597-0058 FDA FDA-2011-D-0597 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring Notice 30 Day Proposed Information Collection 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-01-20T04:59:59Z 2015-12-17T14:54:03Z 2015-31695 0 0 0900006481db6a1d
FDA-2011-D-0164-0011 FDA FDA-2011-D-0164 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Notice 30 Day Proposed Information Collection 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-01-20T04:59:59Z 2015-12-18T22:00:50Z 2015-31696 0 0 0900006481db6b0a
FDA-2015-D-4562-0001 FDA FDA-2015-D-4562 Safety Assessment for Investigational New Drug Application Safety Reporting; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z 2016-02-17T04:59:59Z 2016-02-17T22:01:26Z 2015-31690 0 0 0900006481db6ac5
FDA-2010-D-0226-0026 FDA FDA-2010-D-0226 Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase Notice Notice of Termination 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z   2015-12-17T15:07:46Z 2015-31692 0 0 0900006481db6ac6
FDA-2015-N-0001-0110 FDA FDA-2015-N-0001 The Twentieth Food and Drug Administration International Separation Science Society Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products—WCBP 2016 Notice Meeting 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z   2015-12-17T15:20:47Z 2015-31691 0 0 0900006481db6bb8
FDA-2001-N-0075-0016 FDA Regulation for establishing import tolerances FDA-2001-N-0075 Import Tolerances; Extension of Comment Period Notice Notice of Extension 2015-12-16T05:00:00Z 2015 12 2001-12-07T05:00:00Z 2002-03-12T04:59:59Z 2015-12-16T22:01:08Z   0 0 09000064804b8337
FDA-2001-N-0075-0014 FDA Regulation for establishing import tolerances FDA-2001-N-0075 Import Tolerances; Advance Notice of Proposed Rulemaking Notice General Notice 2015-12-16T05:00:00Z 2015 12 2001-08-10T04:00:00Z 2001-12-02T04:59:59Z 2015-12-16T22:01:04Z   0 0 09000064804b8332
FDA-2012-N-0873-0003 FDA FDA-2012-N-0873 Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products Notice 60 Day Proposed Information Collection 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-02-17T04:59:59Z 2015-12-24T22:00:48Z 2015-31402 0 0 0900006481da73c2
FDA-2014-E-0182-0006 FDA FDA-2014-E-0182 Determination of Regulatory Review Period for Purposes of Patent Extension; VIZAMYL Notice Determinations 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-02-17T04:59:59Z 2015-12-15T15:50:05Z 2015-31401 0 0 0900006481da740f
FDA-2015-D-0288-0016 FDA FDA-2015-D-0288 Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z   2015-12-15T15:30:27Z 2015-31407 0 0 0900006481da7326
FDA-2015-N-4462-0001 FDA FDA-2015-N-4462 Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments Notice Public Meetings 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-02-26T04:59:59Z 2015-12-15T15:12:03Z 2015-31404 0 0 0900006481da6b39
FDA-2015-D-4561-0001 FDA FDA-2015-D-4561 Head Lice Infestation: Developing Drugs for Topical Treatment; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-03-15T03:59:59Z 2016-03-16T20:00:25Z 2015-31406 0 0 0900006481da7377
FDA-2013-D-1143-0049 FDA FDA-2013-D-1143 Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-03-15T03:59:59Z 2016-08-31T16:43:07Z 2015-31405 0 0 0900006481da74bd
FDA-2013-E-1575-0005 FDA FDA-2013-E-1575 Determination of Regulatory Review Period for Purposes of Patent Extension; RAXIBACUMAB Notice Determinations 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-02-17T04:59:59Z 2015-12-15T16:00:10Z 2015-31400 0 0 0900006481da7506
FDA-2013-E-1694-0006 FDA FDA-2013-E-1694 Determination of Regulatory Review Period for Purposes of Patent Extension; Trivascular Ovation Abdominal Stent Graft System Notice Determinations 2015-12-15T05:00:00Z 2015 12 2015-12-15T05:00:00Z 2016-02-17T04:59:59Z 2015-12-15T15:20:17Z 2015-31397 0 0 0900006481da72c8
FDA-2015-N-0001-0109 FDA FDA-2015-N-0001 Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Public Meetings 2015-12-14T05:00:00Z 2015 12 2015-12-14T05:00:00Z   2015-12-14T14:54:07Z 2015-31372 0 0 0900006481da1ef0
FDA-1998-N-0088-0026 FDA Exports: Notification and Recordkeeping requirements FDA-1998-N-0088 Exports: Notification and Recordkeeping Requirements; Final Rule Notice Notice of Final Rule 2015-12-14T05:00:00Z 2015 12 2015-12-14T05:00:00Z   2015-12-14T15:16:02Z   0 0 0900006480585e1f
FDA-2014-E-0309-0006 FDA FDA-2014-E-0309 Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T17:04:57Z 2015-31097 0 0 0900006481d9aed7
FDA-2014-E-0308-0006 FDA FDA-2014-E-0308 Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T17:02:40Z 2015-31097 0 0 0900006481d9ac0d
FDA-2014-E-0265-0005 FDA FDA-2014-E-0265 Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T16:59:04Z 2015-31098 0 0 0900006481d9ac0e
FDA-2014-E-0279-0006 FDA FDA-2014-E-0279 Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T19:24:05Z 2015-31096 0 0 0900006481d9ab78
FDA-2014-E-0271-0006 FDA FDA-2014-E-0271 Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T17:09:17Z 2015-31095 0 0 0900006481d9ac0b
FDA-2013-N-0093-0006 FDA FDA-2013-N-0093 Agency Information Collection Activities: Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts Notice 60 Day Proposed Information Collection 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T17:15:29Z 2015-31100 0 0 0900006481d9ab7a
FDA-2013-E-1573-0005 FDA FDA-2013-E-1573 Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX Notice Determinations 2015-12-10T05:00:00Z 2015 12 2015-12-10T05:00:00Z 2016-02-09T04:59:59Z 2015-12-10T16:53:17Z 2015-31099 0 0 0900006481d9ac55
FDA-2015-D-4380-0001 FDA FDA-2015-D-4380 Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability Notice Notice of Availability 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z 2016-02-09T04:59:59Z 2016-02-08T22:00:59Z 2015-30931 0 0 0900006481d9267b
FDA-2015-N-2881-0002 FDA FDA-2015-N-2881 Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period Notice Extension of Comment Period 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z 2015-12-25T04:59:59Z 2015-12-25T22:00:33Z 2015-30937 0 0 0900006481d92514
FDA-2015-D-2261-0008 FDA FDA-2015-D-2261 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z   2015-12-09T14:59:09Z 2015-30972 0 0 0900006481d92624
FDA-2015-N-0001-0108 FDA FDA-2015-N-0001 Psychopharmacologic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z   2015-12-09T14:34:06Z 2015-30970 0 0 0900006481d92025
FDA-2015-N-3015-0002 FDA FDA-2015-N-3015 Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Reopening of Comment Period Notice Meeting 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z 2015-12-25T04:59:59Z 2015-12-24T22:00:48Z 2015-30936 0 0 0900006481d92622
FDA-2014-N-1286-0011 FDA FDA-2014-N-1286 Moving Forward: Collaborative Approaches to Medical Device Cybersecurity; Public Workshop; Request for Comments Notice Meeting 2015-12-07T05:00:00Z 2015 12 2015-12-07T05:00:00Z 2016-02-23T04:59:59Z 2016-02-23T02:00:36Z 2015-30772 0 0 0900006481d89594
FDA-2015-N-4399-0001 FDA FDA-2015-N-4399 Determination That OPHTHAINE (proparacaine hydrochloride) Solution and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-12-04T05:00:00Z 2015 12 2015-12-04T05:00:00Z   2015-12-04T15:26:05Z 2015-30628 0 0 0900006481d85a4f
FDA-2014-D-2175-0001 FDA FDA-2014-D-2175 Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-03T05:00:00Z 2015 12 2015-12-03T05:00:00Z 2015-03-03T04:59:59Z 2015-12-03T15:01:08Z 2015-30589 0 0 0900006481d82bc1
FDA-2010-N-0155-0222 FDA FDA-2010-N-0155 Veterinary Feed Directive Common Format Questions and Answers; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-01T05:00:00Z 2015 12 2015-12-01T05:00:00Z 2016-02-02T04:59:59Z 2016-08-23T12:38:42Z 2015-30411 0 0 0900006481d7c706
FDA-2015-N-0001-0107 FDA FDA-2015-N-0001 Psychopharmacologic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2015-11-30T05:00:00Z 2015 11 2015-11-30T05:00:00Z   2015-11-30T15:04:05Z 2015-30296 0 0 0900006481d7961c
FDA-2015-N-0001-0106 FDA FDA-2015-N-0001 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting Notice Meeting 2015-11-27T05:00:00Z 2015 11 2015-11-27T05:00:00Z   2015-11-27T19:00:44Z 2015-30121 0 0 0900006481d762ed
FDA-2015-N-4166-0001 FDA FDA-2015-N-4166 Public Meeting on Patient-Focused Drug Development for Psoriasis Notice Meeting 2015-11-25T05:00:00Z 2015 11 2015-11-25T05:00:00Z 2016-05-18T03:59:59Z 2016-05-18T04:00:33Z 2015-29992 0 0 0900006481d724c6
FDA-2015-P-1153-0005 FDA FDA-2015-P-1153 Determination That TYLENOL WITH CODEINE (Acetaminophen With Codeine Phosphate) Oral Tablets, 325 Milligrams/7.5 Milligrams, 325 Milligrams/15 Milligrams, 325 Milligrams/30 Milligrams, and 325 Milligrams/60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-11-25T05:00:00Z 2015 11 2015-11-25T05:00:00Z   2015-11-25T16:14:27Z 2015-30051 0 0 0900006481d72983
FDA-2012-D-1197-0010 FDA FDA-2012-D-1197 Certification Process for Designated Medical Gases; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-25T05:00:00Z 2015 11 2015-11-25T05:00:00Z 2016-01-26T04:59:59Z 2016-01-25T22:01:02Z 2015-29989 0 0 0900006481d729d6
FDA-2015-D-4272-0001 FDA FDA-2015-D-4272 Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-24T05:00:00Z 2015 11 2015-11-24T05:00:00Z 2016-01-26T04:59:59Z 2016-05-31T18:45:30Z 2015-29904 0 0 0900006481d6d347
FDA-2015-D-3990-0001 FDA FDA-2015-D-3990 Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-23T05:00:00Z 2015 11 2015-11-23T05:00:00Z 2016-01-23T04:59:59Z 2015-12-01T20:08:06Z 2015-29635 0 0 0900006481d6933a
FDA-2015-N-0001-0105 FDA FDA-2015-N-0001 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Meeting 2015-11-23T05:00:00Z 2015 11 2015-11-23T05:00:00Z   2015-11-23T14:24:47Z 2015-29768 0 0 0900006481d6881b
FDA-2015-D-4033-0001 FDA FDA-2015-D-4033 Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-23T05:00:00Z 2015 11 2015-11-23T05:00:00Z 2016-01-23T04:59:59Z 2019-06-19T16:15:59Z 2015-29637 0 0 0900006481d6944a
FDA-2015-D-4021-0001 FDA FDA-2015-D-4021 Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-23T05:00:00Z 2015 11 2015-11-23T05:00:00Z 2016-01-23T04:59:59Z 2015-12-20T00:54:08Z 2015-29636 0 0 0900006481d69941
FDA-2015-D-4012-0001 FDA FDA-2015-D-4012 Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-11-23T05:00:00Z 2015 11 2015-11-23T05:00:00Z 2016-01-23T04:59:59Z 2015-12-01T20:18:02Z 2015-29634 0 0 0900006481d69942
FDA-2015-P-3404-0004 FDA FDA-2015-P-3404 Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-11-20T05:00:00Z 2015 11 2015-11-20T05:00:00Z   2015-12-01T20:22:32Z 2015-29639 0 0 0900006481d5e0b2
FDA-2012-N-0145-0007 FDA FDA-2012-N-0145 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities Notice 30 Day Proposed Information Collection 2015-11-20T05:00:00Z 2015 11 2015-11-20T05:00:00Z 2015-12-22T04:59:59Z 2015-11-20T14:55:23Z 2015-29663 0 0 0900006481d5e13e
FDA-2015-M-2217-0002 FDA FDA-2015-M-2217 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-11T21:11:27Z 2015-29450 1 0 0900006481d56a57
FDA-2015-M-2219-0002 FDA FDA-2015-M-2219 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:33:15Z 2015-29450 1 0 0900006481d56a5b
FDA-2015-M-2618-0002 FDA FDA-2015-M-2618 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:33:15Z 2015-29450 1 0 0900006481d56a5f
FDA-2015-M-2739-0002 FDA FDA-2015-M-2739 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:34:52Z 2015-29450 1 0 0900006481d56bc9
FDA-2015-M-2218-0002 FDA FDA-2015-M-2218 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-11T21:12:23Z 2015-29450 1 0 0900006481d56a56
FDA-2015-M-2634-0002 FDA FDA-2015-M-2634 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:33:14Z 2015-29450 1 0 0900006481d56a5d
FDA-2015-M-1707-0002 FDA FDA-2015-M-1707 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:35:03Z 2015-29450 1 0 0900006481d5485a
FDA-2015-M-2497-0002 FDA FDA-2015-M-2497 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:33:16Z 2015-29450 1 0 0900006481d56a5a
FDA-2008-D-0530-0014 FDA FDA-2008-D-0530 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Tropical Disease Priority Review Vouchers Notice 30 Day Proposed Information Collection 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z 2015-12-19T04:59:59Z 2015-11-18T16:33:38Z 2015-29406 0 0 0900006481d5490d
FDA-2012-N-0921-0003 FDA FDA-2012-N-0921 Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting; Electronic Submissions Notice 60 Day Proposed Information Collection 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z 2016-01-20T04:59:59Z 2015-11-18T16:39:20Z 2015-29407 0 0 0900006481d54910
FDA-2015-M-2499-0002 FDA FDA-2015-M-2499 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:33:15Z 2015-29450 1 0 0900006481d56a5c
FDA-2013-D-0286-0014 FDA FDA-2013-D-0286 Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability Notice Notice of Availability 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2015-11-18T16:29:20Z 2015-29455 0 0 0900006481d54890
FDA-2015-M-2964-0002 FDA FDA-2015-M-2964 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:34:01Z 2015-29450 1 0 0900006481d56bcb
FDA-2015-M-2584-0002 FDA FDA-2015-M-2584 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:34:52Z 2015-29450 1 0 0900006481d56a5e
FDA-2015-M-2740-0002 FDA FDA-2015-M-2740 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice Notice of Approval 2015-11-18T05:00:00Z 2015 11 2015-11-18T05:00:00Z   2024-11-07T23:34:00Z 2015-29450 1 0 0900006481d56bca
FDA-2014-N-0229-0007 FDA FDA-2014-N-0229 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2015-11-17T05:00:00Z 2015 11 2015-11-17T05:00:00Z   2016-10-03T15:07:12Z 2015-29280 0 0 0900006481d4d4cc
FDA-2012-D-0529-0004 FDA FDA-2012-D-0529 Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Overthe-Counter Human Use—Labeling for Products That Contain Acetaminophen; Guidance for Industry; Availability Notice Notice of Availability 2015-11-17T05:00:00Z 2015 11 2015-11-17T05:00:00Z   2015-11-17T14:30:25Z 2015-29281 0 0 0900006481d4d3e9
FDA-2015-N-0986-0038 FDA FDA-2015-N-0986 Center for Devices and Radiological Health: Experiential Learning Program; General Training Program Notice Announcement 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z 2015-12-17T04:59:59Z 2015-12-17T22:00:26Z 2015-28857 0 0 0900006481d488b6
FDA-2015-N-0001-0104 FDA FDA-2015-N-0001 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice Notice Meeting Postponement 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z   2015-11-16T16:07:25Z 2015-28846 0 0 0900006481d48d0a
FDA-2009-N-0394-0004 FDA FDA-2009-N-0394 Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee Notice Request for Nominations 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z   2015-11-16T14:55:20Z 2015-28847 0 0 0900006481d48817
FDA-1977-N-0356-0016 FDA Single-Entity Coronary Vasodilators FDA-1977-N-0356 Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket Notice Announcement 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z   2024-11-07T23:35:36Z 2015-28853 1 0 0900006481d488ba
FDA-2015-N-3972-0001 FDA FDA-2015-N-3972 Eighth Annual Sentinel Initiative; Public Workshop; Request for Comments Notice Meeting 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z 2016-04-05T03:59:59Z 2015-11-16T15:55:47Z 2015-28851 0 0 0900006481d48d06
FDA-2012-N-0564-0004 FDA FDA-2012-N-0564 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act Notice 30 Day Proposed Information Collection 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z 2015-12-15T04:59:59Z 2015-12-11T22:00:21Z 2015-28788 0 0 0900006481d4039a
FDA-2011-N-0920-2046 FDA FDA-2011-N-0920 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Notice Notice of Approval 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z   2015-11-13T14:45:48Z 2015-28790 0 0 0900006481d40340
FDA-2013-D-1630-0009 FDA FDA-2013-D-1630 Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability Notice Notice of Availability 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z 2016-01-13T04:59:59Z 2016-01-13T22:00:55Z 2015-28804 0 0 0900006481d3f8ea
FDA-2012-D-0049-0030 FDA FDA-2012-D-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act Notice 60 Day Proposed Information Collection 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z 2016-01-13T04:59:59Z 2016-02-29T17:52:47Z 2015-28787 0 0 0900006481d3f8e7
FDA-2011-N-0922-0552 FDA FDA-2011-N-0922 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Notice Notice of Approval 2015-11-13T05:00:00Z 2015 11 2015-11-13T05:00:00Z   2015-11-13T14:19:44Z 2015-28789 0 0 0900006481d401f1
FDA-2015-D-3638-0002 FDA FDA-2015-D-3638 Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability Notice Notice of Availability 2015-11-12T05:00:00Z 2015 11 2015-11-12T05:00:00Z 2016-01-05T04:59:59Z 2015-12-21T22:00:22Z   0 0 0900006481d39851
FDA-2015-N-0001-0103 FDA FDA-2015-N-0001 Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2015-11-12T05:00:00Z 2015 11 2015-11-12T05:00:00Z   2015-11-12T14:30:05Z 2015-28672 0 0 0900006481d3872e

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