Daniel Kracov, Arnold & Porter


The Complete Pharm Exec Guide to PDUFA

The history of prescription drug laws is a complex mix of evolution and politics-in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills-the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)-would both continue existing programs and create new regulatory burdens.