Rollout of ReviewsThese reviews are mandated under FDAAA (505(r)(2)(D)). Once a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number is conducted. Through this project, OSE identified reviews to be completed, completed the reviews, and posted them on the FDA's Postmarketing Drug Safety Evaluations website14. Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA’s website along with a brief discussion of the steps FDA is taking to address any identified safety issues. OSE also issued a press release 15about this new effort to inform the public about the publication of these safety evaluations.Completed1. Identify reviews to be completed4/10/2010Completed4/10/20102. Complete background packages for reviews; signd off and archive in the Document Archiving, Reporting and Regulatory Tracking System (DAARTS)4/26/2010Completed4/26/20103. Write summary narrative for reviews4/30/2010Completed4/30/20104. Obtain clearance for summary reviews6/7/2010Completed6/7/20105. Provide completed summaries to CDER Web Team for posting6/10/2010Completed6/10/20106. Press release6/15/2010Completed6/15/20107. Post on Web6/15/2010Completed6/15/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmPostmarketing Drug Safety Evaluationshttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm215593.htmFDA NEWS RELEASE - FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals ਍††਍਍਍਍਍਍਍