Articles by Daniel Kracov, Arnold & Porter - Pharmaceutical Executive

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Articles by Daniel Kracov, Arnold & Porter

The Complete Pharm Exec Guide to PDUFA

What Congress's grand plans for the "revitalization' of FDA really mean...besides more red tape
Sep 1, 2007

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.

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