CDER Priorities for 2009 Backdrop: FY 2008 2008 Priorities CDER “Lines of Business” Overseeing Drug Development: Selected 2008 Priorities Safety First Safety First: “Equal Voice” Oversee Postmarket Safety and Performance: 2008 Priorities Strengthening Office of Surveillance and Epidemiology Safe Use Initiative Safe Use Overseeing Safety of Marketed Drugs: FDAAA Implementation Safety Surveillance Enhancements MedWatch Plus Ongoing Active Surveillance Pilot Projects Sentinel Initiative Sentinel Initiative: Progress 2008 Priorities: Oversight of Drug Quality Evaluation of Needs for Oversight of Drug Quality in a Global Environment Slide Number 20 Slide Number 21 Slide Number 22 Significant Challenges Dealing with the Reality of Globalization Electronic Drug Registration and Listing Pharmaceutical Quality for the 21st Century: Next Steps 09 Unapproved Drugs Initiative So How Will 2009 Look? 2009 CDER Focus 2009 CDER Focus 2009 CDER Focus 2009 CDER Focus CDER 2009 Focus Summary