2672: A Primer on REMS and the New Era at FDA 2785: FDA Science and Mission at Risk 3009: Regulatory Best Practices for Emerging Companies & First-Time Filers 3056: Policy Developments in Pharmacogenomics Diagnostic Regulation — Case Studies from Australia, Europe and the United States 3104: Is Gaining Drug Approval More Difficult in Europe Than the US, or Vice Versa? 3315: FDA Amendments Act (FDAAA) of 2007: Implementation, Effects on Innovation, and the Impending Debate on "PDUFA V." 3900: FDA Town Hall 3901: EMEA/FDA Town Hall