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The pharmaceutical and biotechnology industry is a major component of the global health economy, of which, the U.S. plays an important role and attracts firms from all over the world to operate and sell products in it. This paper provides an overview of the regulatory environment in the U.S. and reviews relevant finance literature on this industry. Two particular pieces of legislation, the FDA fast track designation and the Orphan Drug Act, both of which have been shown to have significant impact on the financing and product development of firms, are also described in this paper. In addition, this paper surveys the recent U.S. financial market volatility and its effect on firm’s financing opportunity

Understanding Life under Public Scrutiny: The U.S. Bio-pharmaceutical Industry Experience