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<key-projects><projects><title>Advance MCM Regulatory Science Programs</title><description>Support MCM development and evaluation by establishing regulatory science programs for MCM products, based on both intra- and extramural, collaborative research programs.</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>1. Launch MCM regulatory science program by establishing steering committee/governance board</milestone-description><milestone-date>1/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>12/23/2010</milestone-completion-date></row><row><type></type><milestone-description>2. Initiate intramural component of MCM regulatory science program</milestone-description><milestone-date>1/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>1/31/2011</milestone-completion-date></row><row><type></type><milestone-description>3. Co-sponsor with Institute of Medicine (IOM) a public workshop to obtain external stakeholder input on MCM regulatory science needs</milestone-description><milestone-date>3/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/29-30/2011 [1]</milestone-completion-date></row><row><type></type><milestone-description>4. Continue to assess regulatory science needs through formal request for information (RFI)</milestone-description><milestone-date>8/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/19/2011</milestone-completion-date></row><row><type></type><milestone-description>5. Initiate extramural component of the regulatory science program</milestone-description><milestone-date>8/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/19/2011</milestone-completion-date></row><row><type></type><milestone-description>6. Establish an MOU with the DoD’s Defense Advanced Research Projects Agency (DARPA) to collaborate on regulatory science research in support of innovative regulatory tools, such as biomimetic models, that can be used in development and approval of MCMs</milestone-description><milestone-date>12/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>2/7/2011</milestone-completion-date></row><footnotes><note>[1] "Advancing Regulatory Science for Medical Countermeasure Development - A Workshop" was held March 29 - 30, 2011.  For more details, visit &lt;a href=http://www.iom.edu/Activities/Research/DrugForum/2011-MAR-29.aspx target=”_blank”&gt; http://www.iom.edu/Activities/Research/DrugForum/2011-MAR-29.aspx&lt;/a&gt;.</note><note>Additional milestones are currently under development.</note></footnotes></table></projects><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htm</url><text>FDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboard</text></link><link><url>http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm</url><text>Medical Countermeasures Initiative (MCMi)</text></link></related-links></key-projects>
    






