Challenging Pharmaceutical Regulation: Innovation and Public Health in Europe and the United States [Hardcover]

An examination and comparison of the regulation of innovative pharmaceuticals in the US and the EU-wide system of marketing new drugs.

"Challenging Pharmaceutical Regulation" provides the first comparative assessment of the performance of the FDA and the supranational EU since 1995 with respect to therapeutic advance, innovation and public health. In particular, it is the first assessment of the impact of various kinds of accelerated regulatory review in the US and EU since the early 1990s on these regulatory institutions, and on pharmaceutical regulation and innovation in the two super-states more generally.