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withdrawn,object_id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(""Emerging Signals''); Draft Guidance for Industry and Food and Drug 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FDA-2010-D-0434-0028,FDA,FDA-2010-D-0434,Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance,Notice,Withdrawal,2015-12-30T05:00:00Z,2015,12,2015-12-30T05:00:00Z,,2015-12-30T14:04:06Z,2015-32781,0,0,0900006481ddb9fb
FDA-2007-D-0369-0370,FDA,FDA-2007-D-0369,Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability,Notice,Notice of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FDA-2014-D-1318-0001,FDA,FDA-2014-D-1318,"Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability",Notice,Notice of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,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,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,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,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