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withdrawn,object_id FDA-2019-N-5959-56716,FDA,FDA-2019-N-5959,Meeting Summary ORP 2024 05 22 PPLA Listening Session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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,FDA-2019-N-5959,Reference 25 - 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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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,FDA-2019-N-5959,Reference 54 - 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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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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