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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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- 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;