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

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93 rows where docket_id = "FDA-2009-N-0582" sorted by posted_date descending

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document_type 5

  • Supporting & Related Material 86
  • Proposed Rule 3
  • Rule 2
  • Notice 1
  • Other 1

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  • 2010 14
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  • 2012 2

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  • FDA 93
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-N-0582-0132 FDA None FDA-2009-N-0582 TAB A-2016-994-Direct to Consumer-Final Rule-Original Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:49Z   0 0 0900006486375b66
FDA-2009-N-0582-0131 FDA None FDA-2009-N-0582 Direct to Consumer Memorandum Supporting & Related Material Memorandum 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:49Z   0 0 0900006486375b65
FDA-2009-N-0582-0135 FDA None FDA-2009-N-0582 TAB B-2016-994-Direct to Consumer-FRIA-TRACK CHANGE FROM ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:51Z   0 0 0900006486375b69
FDA-2009-N-0582-0134 FDA None FDA-2009-N-0582 TAB B-2016-994-Direct to Consumer-Final Rule-TRACK CHANGE FROM ORIGINAL TO FINAL Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:50Z   0 0 0900006486375b68
FDA-2009-N-0582-0136 FDA None FDA-2009-N-0582 TAB C-2016-994-Direct to Consumer FRIA-Final Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:52Z   0 0 0900006486375b6a
FDA-2009-N-0582-0133 FDA None FDA-2009-N-0582 TAB-A-2016-994-Direct to Consumer-FRIA-Orginal Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:50Z   0 0 0900006486375b67
FDA-2009-N-0582-0137 FDA None FDA-2009-N-0582 TAB C-2016-994-Direct to Consumer-Final Rule-Final Supporting & Related Material Background Material 2024-01-05T05:00:00Z 2024 1     2024-01-05T13:40:52Z   0 0 0900006486375b6b
FDA-2009-N-0582-0130 FDA None FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Rule Final Rule with Request for Comments 2023-12-27T05:00:00Z 2023 12 2023-12-27T05:00:00Z   2023-12-27T14:34:36Z 2023-28530 0 0 090000648635c371
FDA-2009-N-0582-0129 FDA None FDA-2009-N-0582 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice Notice of Approval 2023-12-22T05:00:00Z 2023 12     2024-01-08T13:23:07Z 2023-28290 0 0 0900006486351614
FDA-2009-N-0582-0061 FDA None FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Rule Direct Final Rule 2023-11-21T05:00:00Z 2023 11 2023-11-21T05:00:00Z   2024-01-05T14:03:16Z 2023-25428 0 0 090000648629f6eb
FDA-2009-N-0582-0070 FDA None FDA-2009-N-0582 08 Reference 8 How DTC Spending Shifted in 2020_Medical Marketing and Media_2021 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:16:07Z   0 0 090000648629f8c1
FDA-2009-N-0582-0090 FDA None FDA-2009-N-0582 28 Reference 28 Capacity Limits in Selective Attention Behavioral Evidence and Implications for Neural Activity_Lavie_2001 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:31:22Z   0 0 09000064862a052d
FDA-2009-N-0582-0092 FDA None FDA-2009-N-0582 30 Reference 30 Temporal Methods for Studying Attention How Did We Get Here and Where Are We Going_Shapiro_2001 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:32Z   0 0 09000064862a052f
FDA-2009-N-0582-0115 FDA None FDA-2009-N-0582 53 Reference 53 The Implications of the FTC's Clear and Conspicuous Standards for the Communication of Credit Card Information to Young Consumers_Thomas_2011 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:42:50Z   0 0 09000064862a0679
FDA-2009-N-0582-0105 FDA None FDA-2009-N-0582 43 Reference 43 Aging and Direct-to-Consumer Prescription Drug Television Ads The Effects of Individual Differences and Risk Presentation_O'Donoghue_2019 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:40:54Z   0 0 09000064862a058f
FDA-2009-N-0582-0112 FDA None FDA-2009-N-0582 50 Reference 50 H. Rept. No.102-839_1992 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:42:11Z   0 0 09000064862a05d8
FDA-2009-N-0582-0103 FDA None FDA-2009-N-0582 41 Reference 41 Age Affective Experience and Television Use_Depp_2010 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:40:41Z   0 0 09000064862a05da
FDA-2009-N-0582-0118 FDA None FDA-2009-N-0582 56 Reference 56 Effect of Presentation Modality in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements_Wogalter_2014 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:24Z   0 0 09000064862a06c3
FDA-2009-N-0582-0062 FDA None FDA-2009-N-0582 00 References List CCN Final Rule 10-24-23 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:11:41Z   0 0 090000648629f897
FDA-2009-N-0582-0064 FDA None FDA-2009-N-0582 02 Reference 2 Direct-to-Consumer Advertising of Prescription Drugs and the Patient Prescriber Encounter A Systematic Review_DeFrank_2020 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:12:03Z   0 0 090000648629f899
FDA-2009-N-0582-0076 FDA None FDA-2009-N-0582 14 Reference 14 Factors Influencing Consumers' Attitudinal and Behavioral Responses to Direct-to-Consumer and Over-the-Counter Drug Advertising_Lee_2015 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:17:49Z   0 0 090000648629f8c7
FDA-2009-N-0582-0086 FDA None FDA-2009-N-0582 24 Reference 24 An Integrated Career Coaching and Time-Banking System Promoting FlexibilityWellness and Success A Pilot Program at Stanford University School of Medicine_Fassiotto_2018 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:20:34Z   0 0 09000064862a0528
FDA-2009-N-0582-0088 FDA None FDA-2009-N-0582 26 Reference 26 Draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion_FDA_2009 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:20:50Z   0 0 09000064862a052a
FDA-2009-N-0582-0097 FDA None FDA-2009-N-0582 35 Reference 35 Music is as Distracting as Noise The Differential Distraction of Background Music and Noise on the Cognitive Test Performance of Introverts and Extraverts_Furnham_2002 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:39:39Z   0 0 09000064862a058b
FDA-2009-N-0582-0100 FDA None FDA-2009-N-0582 38 Reference 38 Sources of Miscomprehension in Television Advertising_Hoyer_1984 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:39:57Z   0 0 09000064862a058e
FDA-2009-N-0582-0108 FDA None FDA-2009-N-0582 46 Reference 46 Provision of Effective Information_Baker_2006 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:41:44Z   0 0 09000064862a05dc
FDA-2009-N-0582-0091 FDA None FDA-2009-N-0582 29 Reference 29 The Magical Number Seven Plus or Minus Two Some Limits on Our Capacity for Processing Information_Miller_1956 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:20Z   0 0 09000064862a052e
FDA-2009-N-0582-0099 FDA None FDA-2009-N-0582 37 Reference 37 Distraction and Attitude Change A Resolution_Regan_1973 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:39:51Z   0 0 09000064862a058d
FDA-2009-N-0582-0110 FDA None FDA-2009-N-0582 48 Reference 48 Quantifying Perceived Differences in Type Styles An Exploratory Study_Tantillo_1995 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:41:58Z   0 0 09000064862a0591
FDA-2009-N-0582-0079 FDA None FDA-2009-N-0582 17 Reference 17 Consumers Reports on the Health Effects of Direct-to-Consumer Drug AdvertisingWeissman2003 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:18:38Z   0 0 090000648629f8f6
FDA-2009-N-0582-0083 FDA None FDA-2009-N-0582 21 Reference 21 Time Allocation in Primary Care Office Visits_Tai-Seale_2007 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:19:39Z   0 0 090000648629f8fa
FDA-2009-N-0582-0116 FDA None FDA-2009-N-0582 54 Reference 54 An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements_Aikin_2016 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:00Z   0 0 09000064862a06ad
FDA-2009-N-0582-0109 FDA None FDA-2009-N-0582 47 Reference 47 Text Legibility and the Letter Superiority Effect_Sheedy_2005 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:41:50Z   0 0 09000064862a05de
FDA-2009-N-0582-0125 FDA None FDA-2009-N-0582 63 Reference 63 Defining Audio-Video Redundancy From a Limited-Capacity Information Processing Perspective_Lang_1995 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:22Z   0 0 09000064862a067a
FDA-2009-N-0582-0120 FDA None FDA-2009-N-0582 58 Reference 58 The Empirical Case for Dual Coding_Paivio_1983 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:43Z   0 0 09000064862a067b
FDA-2009-N-0582-0074 FDA None FDA-2009-N-0582 12 Reference 12 Kaiser Health Tracking Poll October 2015_DiJulio_2015 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:17:32Z   0 0 090000648629f8c5
FDA-2009-N-0582-0080 FDA None FDA-2009-N-0582 18 Reference 18 Fair Balance in Direct-to-Consumer Antidepressant Print and Television Advertising_Avery_2012 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:18:51Z   0 0 090000648629f8f7
FDA-2009-N-0582-0089 FDA None FDA-2009-N-0582 27 Reference 27 Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information Technical Research Report_FDA_2011RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:21:06Z   0 0 09000064862a052b
FDA-2009-N-0582-0075 FDA None FDA-2009-N-0582 13 Reference 13 2017 Direct-to-Consumer Advertising Survey Results_Princeton Survey Research Associates for PhRMA_2017 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:17:38Z   0 0 090000648629f8c6
FDA-2009-N-0582-0065 FDA None FDA-2009-N-0582 03 Reference 3 Promotion of Prescription Drugs to Consumers and Providers 20012010_Kornfield_2013 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:12:12Z   0 0 09000064862a084c
FDA-2009-N-0582-0093 FDA None FDA-2009-N-0582 31 Reference 31 Factors That Guide or Disrupt Attentive Visual Processing_Hillstrom_2006 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:38Z   0 0 09000064862a0530
FDA-2009-N-0582-0101 FDA None FDA-2009-N-0582 39 Reference 39 The Effect of Background Music and Background Noise on the Task Performance of Introverts and Extraverts_Cassidy_2007 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:40:21Z   0 0 09000064862a0590
FDA-2009-N-0582-0106 FDA None FDA-2009-N-0582 44 Reference 44 Quantifying and Predicting the Effects of Basic Text Display Variables on the Perceived Urgency of Warning Labels_Adams_1995 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:41:18Z   0 0 09000064862a05d5
FDA-2009-N-0582-0113 FDA None FDA-2009-N-0582 51 Reference 51 The Self-Confidence Advertising Response Relationship A Function of Situational Disctraction_Bither_1973 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:42:23Z   0 0 09000064862a0614
FDA-2009-N-0582-0127 FDA None FDA-2009-N-0582 65 Reference 65 Commission Enforcement Policy Statement in Regard to Clear and Conspicuous Disclosure in Television Advertising_FTC_1970 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:39Z   0 0 09000064862a067f
FDA-2009-N-0582-0096 FDA None FDA-2009-N-0582 34 Reference 34 Comprehension of Info-Aid Supers in Television Advertising for Social Ideas Implications for Public Policy_Manrai_1994 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:58Z   0 0 09000064862a058a
FDA-2009-N-0582-0123 FDA None FDA-2009-N-0582 61 Reference 61 What Effect Do Mixed Sensory Mode Instructional Formats Have on Both Novice and Experienced Learners of Chinese Characters_Chung_2008 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:03Z   0 0 09000064862a06c5
FDA-2009-N-0582-0082 FDA None FDA-2009-N-0582 20 Reference 20 Patients Willing to Wait Arrival Time Wait Time and Patient Satisfaction in an Ambulatory Urology Clinic_Donahue_2017 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:19:10Z   0 0 090000648629f8f9
FDA-2009-N-0582-0084 FDA None FDA-2009-N-0582 22 Reference 22 A Time Motion Study of Primary Care Physicians' Work in the Electronic Health Record Era_Young_2018 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:20:14Z   0 0 090000648629f8fb
FDA-2009-N-0582-0063 FDA None FDA-2009-N-0582 01 Reference 1 Guidance for Industry Consumer-Directed Broadcast Advertisements_FDA_1999 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:11:52Z   0 0 090000648629f898
FDA-2009-N-0582-0066 FDA None FDA-2009-N-0582 04 Reference 4 Trends in Exposure to Televised Prescription Drug Advertising 20032011Kornfield2015 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:15:07Z   0 0 090000648629f89a
FDA-2009-N-0582-0121 FDA None FDA-2009-N-0582 59 Reference 59 The Effects of Audio-Visual and Visual-Only Cues on Consumers Responses to Co-Branded Advertising_Wang_2010 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:49Z   0 0 09000064862a06ae
FDA-2009-N-0582-0072 FDA None FDA-2009-N-0582 10 Reference 10 An Updated Analysis of DTC TV Advertisements for Prescription Drugs_Applequist_2018 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:16:58Z   0 0 090000648629f8c3
FDA-2009-N-0582-0077 FDA None FDA-2009-N-0582 15 Reference 15 Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs Summary of FDA Survey Research Results_Aikin_2004 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:17:59Z   0 0 090000648629f8f4
FDA-2009-N-0582-0111 FDA None FDA-2009-N-0582 49 Reference 49 Effects of Label Format on Knowledge Acquisition and Perceived Readability by Younger and Older Adults_Wogalter_2003 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:42:05Z   0 0 09000064862a05d6
FDA-2009-N-0582-0128 FDA None FDA-2009-N-0582 66 Reference 66 Economic Analysis of Impacts Direct-to-Consumer Prescription Drug Advertisements_FDA_2023 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:49Z   0 0 09000064862a06b2
FDA-2009-N-0582-0104 FDA None FDA-2009-N-0582 42 Reference 42 Prescription Drug Use Continues to Increase U.S. Prescription Drug Data for 20072008 NCHS Data Brief_Gu_2010 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:40:47Z   0 0 09000064862a05dd
FDA-2009-N-0582-0119 FDA None FDA-2009-N-0582 57 Reference 57 Cognitive Psychology In and Out of the Laboratory_Galotti_2004 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:38Z   0 0 09000064862a0676
FDA-2009-N-0582-0117 FDA None FDA-2009-N-0582 55 Reference 55 Attention to and Distraction from Risk Information in Prescription Drug Advertising An Eye Tracking Study_Sullivan_2017 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:07Z   0 0 09000064862a06c0
FDA-2009-N-0582-0094 FDA None FDA-2009-N-0582 32 Reference 32 Distraction Can Enhance or Reduce Yielding to Propaganda Thought Disruption Versus Effort Justification_Petty_1976 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:43Z   0 0 09000064862a0588
FDA-2009-N-0582-0095 FDA None FDA-2009-N-0582 33 Reference 33 Modifying the Impact of Persuasive Communications with External Distraction_Zimbardo_1970 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:32:48Z   0 0 09000064862a0589
FDA-2009-N-0582-0102 FDA None FDA-2009-N-0582 40 Reference 40 Clear and Conspicuous Disclosure_CCH Trade Regulation Reporter_1970 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:40:31Z   0 0 09000064862a05d7
FDA-2009-N-0582-0107 FDA None FDA-2009-N-0582 45 Reference 45 Serifs and Font Legibility_Arditi_2005 Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:41:35Z   0 0 09000064862a05d9
FDA-2009-N-0582-0126 FDA None FDA-2009-N-0582 64 Reference 64 Recall of Television Versus Print News Retesting the Semantic Overlap Hypothesis_Walma_2004 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:32Z   0 0 09000064862a067c
FDA-2009-N-0582-0068 FDA None FDA-2009-N-0582 06 Reference 6 Trends in Urological Direct-to-Consumer Advertising during Prime-Time Television News Programs_Koo_2017 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:15:23Z   0 0 090000648629f8bf
FDA-2009-N-0582-0073 FDA None FDA-2009-N-0582 11 Reference 11 PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines_PhRMA_2008 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:17:18Z   0 0 090000648629f8c4
FDA-2009-N-0582-0069 FDA None FDA-2009-N-0582 07 Reference 7 US Congressional Research Service_Direct-to-Consumer Advertising of Prescription Drugs Report_2009 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:15:34Z   0 0 090000648629f8c0
FDA-2009-N-0582-0078 FDA None FDA-2009-N-0582 16 Reference 16 Scientific Literature on Direct-to-Consumer Advertising of Prescription Pharmaceuticals 20042008 Literature ReviewEastern Research Group2009 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:18:08Z   0 0 090000648629f8f5
FDA-2009-N-0582-0071 FDA None FDA-2009-N-0582 09 Reference 9 The Top 10 Ad Spenders in Big Pharma for 2020_Fierce Pharma_Bulik 2021 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:16:16Z   0 0 090000648629f8c2
FDA-2009-N-0582-0081 FDA None FDA-2009-N-0582 19 Reference 19 Communicating Uncertainties About Prescription Drugs to the Public A National Randomized Trial_Schwartz_2011 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:18:59Z   0 0 090000648629f8f8
FDA-2009-N-0582-0085 FDA None FDA-2009-N-0582 23 Reference 23 Direct-to-Consumer Advertising Physicians' Views of Its Effects on Quality of Care and the Doctor-Patient Relationship_Murray_2003 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:20:26Z   0 0 09000064862a0527
FDA-2009-N-0582-0087 FDA None FDA-2009-N-0582 25 Reference 25 Allocation of Physician Time in Ambulatory Practice A Time and Motion Study in 4 Specialties_Sinsky_2016 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:20:43Z   0 0 09000064862a0529
FDA-2009-N-0582-0124 FDA None FDA-2009-N-0582 62 Reference 62 Using Both an Auditory and a Visual Short-Term Store to Increase Digit Span_Frick_1984 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:44:17Z   0 0 09000064862a061d
FDA-2009-N-0582-0114 FDA None FDA-2009-N-0582 52 Reference 52 Music to Your Brain Background Music Changes Are Processed First Reducing Ad Message Recall_Fraser_2013 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:42:40Z   0 0 09000064862a061b
FDA-2009-N-0582-0098 FDA None FDA-2009-N-0582 36 Reference 36 Processing Deficits and the Mediation of Positive Affect in Persuasion_Mackie_1989 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:39:46Z   0 0 09000064862a058c
FDA-2009-N-0582-0122 FDA None FDA-2009-N-0582 60 Reference 60 Improving Comprehension of Jury Instructions with Audio-Visual Presentation_Brewer_2004 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:43:59Z   0 0 09000064862a06c2
FDA-2009-N-0582-0067 FDA None FDA-2009-N-0582 05 Reference 5 Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects Results From the Health Information National Trends Survey Fourth_Sullivan_2015 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Supporting & Related Material Background Material 2023-11-21T05:00:00Z 2023 11     2023-11-21T22:15:15Z   0 0 090000648629f89b
FDA-2009-N-0582-0055 FDA None FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Reopening of the Comment Period Proposed Rule Notice of Proposed Rulemaking (NPRM) 2012-03-23T04:00:00Z 2012 3 2012-03-23T04:00:00Z 2012-04-10T03:59:59Z 2023-10-25T16:01:08Z 2012-06948 0 0 0900006480fdf3d2
FDA-2009-N-0582-0040 FDA None FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Notice of Availability of Study Data Proposed Rule Notice of Proposed Rulemaking (NPRM) 2012-01-27T05:00:00Z 2012 1 2012-01-27T05:00:00Z 2012-02-28T04:59:59Z 2023-10-25T16:02:27Z 2012-01672 0 0 0900006480fa7047
FDA-2009-N-0582-0017 FDA None FDA-2009-N-0582 OMB Changes, Executive Order 12866 (E.O.)[Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner ] - Reference Other REF-Reference Material (internal attachments) 2010-04-27T04:00:00Z 2010 4 2010-04-27T04:00:00Z   2013-08-11T01:34:04Z   0 0 0900006480ae15c4
FDA-2009-N-0582-0007 FDA None FDA-2009-N-0582 Reference 12 - "IMS Health, Total U.S. Promotional Spend By Type, 2008" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:20:19Z   0 0 0900006480ac9fd4
FDA-2009-N-0582-0008 FDA None FDA-2009-N-0582 Reference 13 - "IMS Health, Integrated Promotional Services™, Year 2008, Data Extracted on September 2009" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:20:40Z   0 0 0900006480ac9fd9
FDA-2009-N-0582-0009 FDA None FDA-2009-N-0582 Reference 15 - "Office of Management and Budget, Circular A-4, Setember 17, 2003" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:21:01Z   0 0 0900006480ac9ffb
FDA-2009-N-0582-0013 FDA None FDA-2009-N-0582 Reference 19 - "Scientific Literature on Direct to Consumer Advertising of Precription Pharmaceuticals, 2004-2008; Eastern Research Group, Inc., Literature Review" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:22:43Z   0 0 0900006480aca060
FDA-2009-N-0582-0003 FDA None FDA-2009-N-0582 Reference 1 - "FDA Guidance for Industry, "Consumer-Directed Broadcast Advertisements," - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:18:52Z   0 0 0900006480ac9f70
FDA-2009-N-0582-0002 FDA None FDA-2009-N-0582 DDMAC References - [Note for MONDAY 3/29/2010 - POST THIS DOCUMENT FIRST BUT AFTER THE FR DOCUMENT AND Please Insert the Title of the FR Notice Here] Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:18:23Z   0 0 0900006480aca149
FDA-2009-N-0582-0001 FDA None FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner Proposed Rule NPR-Notice of Proposed Rule-Making 2010-03-29T04:00:00Z 2010 3 2010-03-29T04:00:00Z 2010-06-29T03:59:59Z 2012-11-30T03:02:04Z 2010-06996 0 0 0900006480aca825
FDA-2009-N-0582-0010 FDA None FDA-2009-N-0582 Reference 16 - "Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, GAO" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:21:25Z   0 0 0900006480aca03c
FDA-2009-N-0582-0006 FDA None FDA-2009-N-0582 Reference 4 - "FDA Draft Guidance for Industry, "Presenting Risk Information in Prescription Drug and Medical Device Promotion," - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:19:59Z   0 0 0900006480ac9f89
FDA-2009-N-0582-0004 FDA None FDA-2009-N-0582 Reference 2 - "CCH Trade Regulation Reporter, Paragraph 7569.09 "Clear and Conspicous Disclosure," Ocober 21, 1970 - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:19:13Z   0 0 0900006480ac9f86
FDA-2009-N-0582-0011 FDA None FDA-2009-N-0582 Reference 17 - "PhRMA Guiding Priniciples; Direct to Consumer Advertisements About Prescription Medicines, Revised December 2008" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:21:45Z   0 0 0900006480aca040
FDA-2009-N-0582-0012 FDA None FDA-2009-N-0582 Reference 18 - "Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs--Summary of FDA Survey Research Results, Final Report, November 19, 2004" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:22:06Z   0 0 0900006480aca044
FDA-2009-N-0582-0005 FDA None FDA-2009-N-0582 Reference 3 - "See H. Rept. No. 102-839, August 11, 1992" - Background Supporting & Related Material BKG-Background Material 2010-03-29T04:00:00Z 2010 3     2010-03-29T15:19:36Z   0 0 0900006480ac9f87

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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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