Agency Information Collection Activities; Proposals, Submissions, and Approvals: Communicating Composite Scores in Direct-to-Consumer Advertising

Document ID: FDA-2012-N-0892-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2012-20783
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Details Information

Document Subtype: General Notice
Received Date: August 23 2012, at 12:00 AM Eastern Daylight Time
Start-End Page: 51027 - 51030
Page Count: 4
Comment Start Date: August 23 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: October 22 2012, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 From Idea to Market The Drug Approval Process

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Reference 2 Guidance of Industry Postmarketing Studies and Clinical Trials Implementatioon of Section 505 (o)(3) of the Federal Food Drug and Cosmetic Act

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Reference 3 A Historical Perspective of Elevated Systolic vs Diastolic Blood Pressure From an Epidemiological and Clinical Trial Viewpoint

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Reference 4 Combining Measures Into Composite or Summary Scores

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Reference 5 Measures Development, Methodology, and Oversight Advisory Committee: Recommendations to PCPI Work Groups on Composite Measures

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Reference 6 Quantitative Information

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Reference 7 Numeracy and Decision Making

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Reference 8 The Effects of Numerical Statements of Risk on Trust and Comfort With Hypothetical Physician Risk Communication

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Reference 9 Presenting Risk Information to People With Diabetes: Evaluating Effects and Preferences for Different Formats by a Web-Based Randomized Controlled Trial

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Comments

   
Total: 1
Bausch+Lomb - Comment
Posted: 11/02/2012     ID: FDA-2012-N-0892-0002

Oct 22,2012 11:59 PM ET

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