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<key-projects><projects><title>Evaluation of Standardized Risk Benefit Information</title><description>Determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format to promotional labeling or print advertising would improve healthcare decision making by clinicians, patients, and consumers.</description><dictionary></dictionary><outcome></outcome><accomplishment></accomplishment><free-text></free-text><table><title></title><free-text-table></free-text-table><overall-status><briefing>ON TRACK</briefing><prior-briefing>ON TRACK</prior-briefing></overall-status><row><type></type><milestone-description>A. Submit first progress report to Congress</milestone-description><milestone-date>3/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/23/2011</milestone-completion-date></row><row><type></type><milestone-description>B. Receive draft literature review summarizing the scientific evidence and research on decision making and social and cognitive psychology</milestone-description><milestone-date>8/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/1/2011</milestone-completion-date></row><row><type></type><milestone-description>C. Present results of the literature review to the FDA Risk Communications Advisory Committee for their review and recommendations</milestone-description><milestone-date>11/17/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/17/2011</milestone-completion-date></row><row><type></type><milestone-description>D. Complete quantitative research study of the value of adding quantitative information to direct-to-consumer (DTC) print and television advertisements</milestone-description><milestone-date>8/30/2011</milestone-date><milestone-date>&lt;i&gt;(11/1/2011)&lt;/i&gt;</milestone-date><milestone-date>&lt;i&gt;(6/15/2012)&lt;/i&gt;</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/30/2012</milestone-completion-date></row><row><type></type><milestone-description>E. Complete display page research study of how physicians and consumers make risk benefit assessments and how consumers make such assessments in response to variations in the display page of DTC print ads</milestone-description><milestone-date>3/1/2012</milestone-date><milestone-date>&lt;i&gt;(6/1/2012)&lt;/i&gt;</milestone-date><milestone-date>&lt;i&gt;(9/1/2012)&lt;/i&gt;</milestone-date><milestone-date>&lt;i&gt;(3/1/2013)&lt;/i&gt;</milestone-date><milestone-status>On Track</milestone-status><milestone-completion-date></milestone-completion-date></row><row><type></type><milestone-description>F. Complete format research study of the type of information that could be presented in a standardized "box" and how qualitative information might be included</milestone-description><milestone-date>9/1/2012</milestone-date><milestone-date>&lt;i&gt;(4/1/2013)&lt;/i&gt;</milestone-date><milestone-status>On Track</milestone-status><milestone-completion-date></milestone-completion-date></row><row><type></type><milestone-description>G. Submit second progress report to Congress</milestone-description><milestone-date>3/31/2012</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>6/4/2012</milestone-completion-date></row><row><type></type><milestone-description>H. Submit third progress report to Congress</milestone-description><milestone-date>3/31/2013</milestone-date><milestone-status>On Track</milestone-status><milestone-completion-date></milestone-completion-date></row><row><type></type><milestone-description>I. Submit final report to Congress</milestone-description><milestone-date>9/30/2013</milestone-date><milestone-status>Not Yet Started</milestone-status><milestone-completion-date></milestone-completion-date></row><footnotes><note>(1) As research progresses, approaches and strategies can change including the milestones listed under each project. In instances where research approaches and strategies change and milestones and dates are affected, the revised milestone date will be provided in italics under the original milestone date.</note><note>(2) Research timelines are dependent on timing of OMB approval of data collection instruments.</note></footnotes></table></projects><glossary></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm237975.htm</url><text>FDA-TRACK Health Care Reform Dashboard</text></link></related-links></key-projects>
    






