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86 rows where agency_id = "FDA" and docket_id = "FDA-2019-N-5959" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 84
  • Other 1
  • Proposed Rule 1

posted_year 2

  • 2023 78
  • 2024 8

agency_id 1

  • FDA · 86 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-N-5959-56716 FDA None FDA-2019-N-5959 Meeting Summary ORP 2024 05 22 PPLA Listening Session PMI Other Minutes 2024-06-07T04:00:00Z 2024 6 2024-06-07T04:00:00Z   2024-06-07T15:19:59Z   0 0 090000648659e259
FDA-2019-N-5959-50875 FDA None FDA-2019-N-5959 TAB A - 2012-117 - Medication Guides - PRIA - Original Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:30:25Z   0 0 0900006486376022
FDA-2019-N-5959-50874 FDA None FDA-2019-N-5959 Medication Guides -12866 Post Publication Package Memo -12-22-2023 Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:30:11Z   0 0 0900006486376021
FDA-2019-N-5959-50879 FDA None FDA-2019-N-5959 TAB C - 2012-117 - Medication Guides - PRIA - Final Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:32:08Z   0 0 090000648637606e
FDA-2019-N-5959-50876 FDA None FDA-2019-N-5959 TAB A -2012-117 - Medication Guides -Proposed Rule - Original Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:30:45Z   0 0 0900006486376069
FDA-2019-N-5959-50878 FDA None FDA-2019-N-5959 TAB B - 2012-117- Medication Guides - Rule - TRACK CHANGE - ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:31:54Z   0 0 090000648637606d
FDA-2019-N-5959-50880 FDA None FDA-2019-N-5959 TAB C - 2012-117 - Medication Guides - Proposed Rule - Final Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:32:43Z   0 0 090000648637606f
FDA-2019-N-5959-50877 FDA None FDA-2019-N-5959 TAB B - 2012-117 -Medication Guides -PRIA -TRACK CHANGE FROM ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-01-04T05:00:00Z 2024 1     2024-01-04T13:31:09Z   0 0 090000648637606a
FDA-2019-N-5959-0101 FDA None FDA-2019-N-5959 Reference 48 - Preliminary Regulatory Impact Analysis--Initial Regulatory Flexibility Analysis and Unfunded Mandates Reform Act Analysis for Medication Guides--PMI RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-16T04:00:00Z 2023 6     2023-06-16T18:21:16Z   0 0 0900006485adf12f
FDA-2019-N-5959-0051 FDA None FDA-2019-N-5959 Reference 49 - Consumers Better Understand and Prefer Simplified Written Drug Information: An Evaluation of 2 Novel Formats Versus the Current CMI - 2013 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:31:07Z   0 0 0900006485a969fe
FDA-2019-N-5959-0053 FDA None FDA-2019-N-5959 Reference 51 - Medication adherence: A call for action - 2011 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:31:36Z   0 0 0900006485a969ff
FDA-2019-N-5959-0032 FDA None FDA-2019-N-5959 Reference 29 - Exploring the Promise of Patient Medication Information July 1, 2014 - Meeting Summary RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:27:03Z   0 0 0900006485a94a2d
FDA-2019-N-5959-0033 FDA None FDA-2019-N-5959 Reference 30 - FDA Public Hearing - Development and Distribution of Patient Medication Information for Prescription Drugs - 2010 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:26:24Z   0 0 0900006485a94a2e
FDA-2019-N-5959-0041 FDA None FDA-2019-N-5959 Reference 38 - Usability of FDA-Approved Medication Guides - 2012 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:28:59Z   0 0 0900006485a94a34
FDA-2019-N-5959-0044 FDA None FDA-2019-N-5959 Reference 41 - Designing Instructional and Informational Text - 2004 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:29:38Z   0 0 0900006485a94c31
FDA-2019-N-5959-0020 FDA None FDA-2019-N-5959 Reference 17 - FDA Minutes of the Risk Communication Advisory Committee -February 26-27, 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:05:13Z   0 0 0900006485a94951
FDA-2019-N-5959-0012 FDA None FDA-2019-N-5959 Reference 09 - Steering Committee for the Collaborative Development of a Long- Range Action Plan for the Provision of Useful Prescription Medicine Information - 1996 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:01:58Z   0 0 0900006485a9479d
FDA-2019-N-5959-0057 FDA None FDA-2019-N-5959 Reference 55 - Willingness to pay to standardize patient medication information - 2021 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:33:02Z   0 0 0900006485a970f0
FDA-2019-N-5959-0070 FDA None FDA-2019-N-5959 Reference 68 - Experimental Study of Patient Information Prototypes RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:36:58Z   0 0 0900006485a99169
FDA-2019-N-5959-0072 FDA None FDA-2019-N-5959 Reference 70 - Preferences for Patient Medication Information: What Do Patients Want? RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:37:22Z   0 0 0900006485a991be
FDA-2019-N-5959-0048 FDA None FDA-2019-N-5959 Reference 45 - Effects of Headings on Text Summarization - 2001 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:30:26Z   0 0 0900006485a94c33
FDA-2019-N-5959-0069 FDA None FDA-2019-N-5959 Reference 67 - IQVIA 2019 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:36:44Z   0 0 0900006485a99168
FDA-2019-N-5959-0023 FDA None FDA-2019-N-5959 Reference 20 - FDA - Prototype 2 Rheutopia - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:08:14Z   0 0 0900006485a94952
FDA-2019-N-5959-0005 FDA None FDA-2019-N-5959 Reference 02 - Medication Adherence Measures: An Overview - 2015 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T17:59:10Z   0 0 0900006485a94798
FDA-2019-N-5959-0030 FDA None FDA-2019-N-5959 Reference 27 - Designing Pilot Programs to Distribute Patient Medication Information - 2011 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:14:23Z   0 0 0900006485a94957
FDA-2019-N-5959-0011 FDA None FDA-2019-N-5959 Reference 08 - USPHS Healthy People 2000: National Health Promotion and Disease Prevention Objectives and Full Report, with Commentary - 1991 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:01:43Z   0 0 0900006485a9479c
FDA-2019-N-5959-0050 FDA None FDA-2019-N-5959 Reference 47 - Consumer Understanding and Use of Nutrition Labelling: A Systematic Review - 2004 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:30:54Z   0 0 0900006485a94c35
FDA-2019-N-5959-0068 FDA None FDA-2019-N-5959 Reference 66 - IQVIA 2018 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:36:27Z   0 0 0900006485a98d69
FDA-2019-N-5959-0073 FDA None FDA-2019-N-5959 Reference 71 - 2014 FDA Labeling Cost Model RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:37:35Z   0 0 0900006485a99647
FDA-2019-N-5959-0078 FDA None FDA-2019-N-5959 Reference 76 - U.S. Census 2015_SUSB data by employment size RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:38:37Z   0 0 0900006485a996e4
FDA-2019-N-5959-0039 FDA None FDA-2019-N-5959 Reference 36 - Written Medicines Information for South African HIV-AIDS Patients: Does It Enhance Understanding of Co-Trimoxazole Therapy? - 2007 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:28:34Z   0 0 0900006485a94a33
FDA-2019-N-5959-0045 FDA None FDA-2019-N-5959 Reference 42 - Interpretation of Medication Pictograms by Adults in the UK - 2005 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:29:48Z   0 0 0900006485a94bd7
FDA-2019-N-5959-0049 FDA None FDA-2019-N-5959 Reference 46 - The Effects of Headings in Information Mapping on Search Speed and Evaluation of a Brief Health Education Text - 2007 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:30:41Z   0 0 0900006485a94c34
FDA-2019-N-5959-0028 FDA None FDA-2019-N-5959 Reference 25 - Expert Workshop: The Science of Communicating Medication Information to Consumers - 2010 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:04:08Z   0 0 0900006485a94955
FDA-2019-N-5959-0018 FDA None FDA-2019-N-5959 Reference 15 - National Association of Chain Drug Stores - Citizen Petition Requesting FDA Action on a "One Document Solution" for All Pharmacy-Based Communications - 2008 - Docket FDA-2008-P-0380 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:03:50Z   0 0 0900006485a8e581
FDA-2019-N-5959-0021 FDA None FDA-2019-N-5959 Reference 18 - FDA - Providing Effective Information to Consumers About Prescription Drug Risks and Benefits - The Issues Paper - Background Paper - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:07:20Z   0 0 0900006485a8e582
FDA-2019-N-5959-0075 FDA None FDA-2019-N-5959 Reference 73 - Drug Therapy Adherence to Medication RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:38:01Z   0 0 0900006485a991c5
FDA-2019-N-5959-0029 FDA None FDA-2019-N-5959 Reference 26 - Ensuring Access to Effective Patient Medication Information - 2010 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:04:20Z   0 0 0900006485a94956
FDA-2019-N-5959-0061 FDA None FDA-2019-N-5959 Reference 59 - Unique Device Identification System; Final Rule RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:33:52Z   0 0 0900006485a9871a
FDA-2019-N-5959-0038 FDA None FDA-2019-N-5959 Reference 35 - Patients Use and Perception of Medication Information Leaflets - 2007 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:28:17Z   0 0 0900006485a94a32
FDA-2019-N-5959-0047 FDA None FDA-2019-N-5959 Reference 44 - Prescription Painkillers and Controlled Substances: An Appraisal of Drug Information Provided by Six US Pharmacies - 2013 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:30:12Z   0 0 0900006485a94c32
FDA-2019-N-5959-0055 FDA None FDA-2019-N-5959 Reference 53 - May 2020 National Industry-Specific Occupational Employment and Wage Estimates NAICS 325400 - Pharmaceutical and Medicine Manufacturing RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:32:37Z   0 0 0900006485a96b84
FDA-2019-N-5959-0037 FDA None FDA-2019-N-5959 Reference 34 - Consumers Better Understand and Prefer Simplified Written Drug Information--An Evaluation of 2 Novel Formats Versus the Current CMI - 2013 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:28:04Z   0 0 0900006485a9495a
FDA-2019-N-5959-0035 FDA None FDA-2019-N-5959 Reference 32 - Factors Influencing Consumer Use of Written Drug Information - 2003 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:27:37Z   0 0 0900006485a94a30
FDA-2019-N-5959-0042 FDA None FDA-2019-N-5959 Reference 39 - ER-LA Opioid Analgesics REMS - The Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy - 2014 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:29:13Z   0 0 0900006485a94a35
FDA-2019-N-5959-0040 FDA None FDA-2019-N-5959 Reference 37 - Patient Information Leaflets - Patients' Comprehension of Information About Interactions and Contraindications - 2005 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:28:46Z   0 0 0900006485a94bd6
FDA-2019-N-5959-0010 FDA None FDA-2019-N-5959 Reference 07 - An update on medication guides - 2017 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:01:28Z   0 0 0900006485a8e57e
FDA-2019-N-5959-0022 FDA None FDA-2019-N-5959 Reference 19 - FDA - Prototype 1 Rheutopia - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:07:37Z   0 0 0900006485a8e583
FDA-2019-N-5959-0006 FDA None FDA-2019-N-5959 Reference 03 - Nonadherence to antihypertensive drugs - A systematic review and meta-analysis - 2017 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T17:59:22Z   0 0 0900006485a8e57d
FDA-2019-N-5959-0014 FDA None FDA-2019-N-5959 Reference 11 - Expert and Consumer Evaluation of Patient Medication Leaflets Provided in U.S. Pharmacies - 2005 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:02:26Z   0 0 0900006485a9479f
FDA-2019-N-5959-0067 FDA None FDA-2019-N-5959 Reference 65 - Evergreening, patent challenges, and effective market life in pharmaceuticals RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:35:26Z   0 0 0900006485a98d68
FDA-2019-N-5959-0077 FDA None FDA-2019-N-5959 Reference 75 - Table of Small Business Size Standards Matched to North American Industry Classification System Codes RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:38:27Z   0 0 0900006485a99650
FDA-2019-N-5959-0066 FDA None FDA-2019-N-5959 Reference 64 - Attitudes and Beliefs About the Use of Over-the-Counter Medicines: A Dose of Reality RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:35:17Z   0 0 0900006485a98d67
FDA-2019-N-5959-0074 FDA None FDA-2019-N-5959 Reference 72 - Patients' Use and Perception of Medication Information Leaflets RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:37:48Z   0 0 0900006485a99648
FDA-2019-N-5959-0004 FDA None FDA-2019-N-5959 Reference 01 - Evaluation of Written Prescription Information Provided in Community Pharmacies: A Study in Eight States - 2003 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-01T21:40:43Z   0 0 0900006485a8cc61
FDA-2019-N-5959-0059 FDA None FDA-2019-N-5959 Reference 57 - The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:33:25Z   0 0 0900006485a984af
FDA-2019-N-5959-0062 FDA None FDA-2019-N-5959 Reference 60 - Orange Book RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:34:03Z   0 0 0900006485a9871b
FDA-2019-N-5959-0079 FDA None FDA-2019-N-5959 Reference 77 - A critical review of FDA-approved Medication Guides - 2006 RE Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:38:49Z   0 0 0900006485a9e27f
FDA-2019-N-5959-0056 FDA None FDA-2019-N-5959 Reference 54 - May 2020 National Occupational Employment and Wage Estimates United States RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:32:49Z   0 0 0900006485a96b89
FDA-2019-N-5959-0076 FDA None FDA-2019-N-5959 Reference 74 - Do patients see, read and retain the new mandatory medicines information leaflets? RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:38:14Z   0 0 0900006485a996e2
FDA-2019-N-5959-0058 FDA None FDA-2019-N-5959 Reference 56 - Variations in Patients’ Adherence to Medical Recommendations A Quantitative Review of 50 Years of Research RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:33:12Z   0 0 0900006485a9858c
FDA-2019-N-5959-0065 FDA None FDA-2019-N-5959 Reference 63 - Effective Patent Life in Pharmaceuticals RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:34:39Z   0 0 0900006485a98ae8
FDA-2019-N-5959-0064 FDA None FDA-2019-N-5959 Reference 62 - FDA 2020b - Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations to Date RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:34:27Z   0 0 0900006485a9e27e
FDA-2019-N-5959-0034 FDA None FDA-2019-N-5959 Reference 31 - Preferences for Patient Medication Information: What Do Patients Want? - 2014 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:26:44Z   0 0 0900006485a94a2f
FDA-2019-N-5959-0046 FDA None FDA-2019-N-5959 Reference 43 - Assessing Readability of Patient Education Materials - Current Role in Orthopaedics - 2010 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:30:01Z   0 0 0900006485a94bd8
FDA-2019-N-5959-0031 FDA None FDA-2019-N-5959 Reference 28 - Making Prescription Medication Information User-Friendly: The Time Has Come - 2013 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:25:54Z   0 0 0900006485a94958
FDA-2019-N-5959-0007 FDA None FDA-2019-N-5959 Reference 04 - Medication Adherence: The Elephant in the Room - 2018 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T17:59:36Z   0 0 0900006485a94799
FDA-2019-N-5959-0008 FDA None FDA-2019-N-5959 Reference 05 - Economic impact of medication nonadherence by disease groups: a systematic review - 2018 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:00:10Z   0 0 0900006485a9479a
FDA-2019-N-5959-0027 FDA None FDA-2019-N-5959 Reference 24 - Exploring the Promise of Patient Medication Information July 1, 2014 - Meeting Summary RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:09:26Z   0 0 0900006485a94a2c
FDA-2019-N-5959-0060 FDA None FDA-2019-N-5959 Reference 58 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:33:40Z   0 0 0900006485a97f83
FDA-2019-N-5959-0071 FDA None FDA-2019-N-5959 Reference 69 - Expert and Consumer Evaluation of Consumer Medication Information ‐ 2008 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:37:09Z   0 0 0900006485a991bd
FDA-2019-N-5959-0054 FDA None FDA-2019-N-5959 Reference 52 - Influence of patient medication information format on comprehension and application of medication information: A randomized, controlled experiment - 2015 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:31:48Z   0 0 0900006485a96e24
FDA-2019-N-5959-0016 FDA None FDA-2019-N-5959 Reference 13 - Expert and Consumer Evaluation of Consumer Medication Information ‐ 2008 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:03:06Z   0 0 0900006485a8e580
FDA-2019-N-5959-0024 FDA None FDA-2019-N-5959 Reference 21 - FDA - Prototype 3 Rheutopia - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:08:27Z   0 0 0900006485a94953
FDA-2019-N-5959-0036 FDA None FDA-2019-N-5959 Reference 33 - Providing Patients with Written Medication Information - 1998 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:27:52Z   0 0 0900006485a94a31
FDA-2019-N-5959-0043 FDA None FDA-2019-N-5959 Reference 40 - Key Principles to Guide Development of Consumer Medicine Information - Content Analysis of Information Design Texts - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:29:25Z   0 0 0900006485a94c30
FDA-2019-N-5959-0015 FDA None FDA-2019-N-5959 Reference 12 - Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:02:50Z   0 0 0900006485a8e57f
FDA-2019-N-5959-0017 FDA None FDA-2019-N-5959 Reference 14 - Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:03:23Z   0 0 0900006485a947a0
FDA-2019-N-5959-0025 FDA None FDA-2019-N-5959 Reference 22 - FDA Prototype 4 Rheutopia - 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:08:43Z   0 0 0900006485a94954
FDA-2019-N-5959-0026 FDA None FDA-2019-N-5959 Reference 23 - FDA - Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop Summary - September 24-25, 2009 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:09:08Z   0 0 0900006485a8e584
FDA-2019-N-5959-0009 FDA None FDA-2019-N-5959 Reference 06 - Health Literacy, Processing Capacity, Illness Knowledge, and Actionable Memory for Medication Taking in Type 2 Diabetes: Cross-Sectional Analysis - 2021 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:01:11Z   0 0 0900006485a9479b
FDA-2019-N-5959-0013 FDA None FDA-2019-N-5959 Reference 10 - FDA Public Workshop on Current Status of Useful Written Prescription Drug Information for Patient - Meeting Summary - 2000 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:02:13Z   0 0 0900006485a9479e
FDA-2019-N-5959-0019 FDA None FDA-2019-N-5959 Reference 16 - National Association of Chain Drug Stores - Withdrawal of Citizen Petition Requesting FDA Action on a "One Document Solution" for All Pharmacy-Based Communications - 2010 - Docket FDA-2008-P-0380-0008 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T18:04:20Z   0 0 0900006485a947a1
FDA-2019-N-5959-0052 FDA None FDA-2019-N-5959 Reference 50 - Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices - 2017 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:31:22Z   0 0 0900006485a96e20
FDA-2019-N-5959-0063 FDA None FDA-2019-N-5959 Reference 61 - FDA 2020 RE Medication Guides: Patient Medication Information Supporting & Related Material Background Material 2023-06-01T04:00:00Z 2023 6     2023-06-08T19:34:15Z   0 0 0900006485a98d63
FDA-2019-N-5959-0001 FDA None FDA-2019-N-5959 Medication Guides: Patient Medication Information Proposed Rule Amendment 2023-05-31T04:00:00Z 2023 5 2023-05-31T04:00:00Z 2023-11-28T04:59:59Z 2024-09-05T01:00:43Z 2023-11354 0 0 0900006485a9510f

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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