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Regulatory Review Time and Pharmaceutical R&D

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  • Chorniy, Anna
  • Bailey, James
  • Maloney, Michael
  • Civan, Abdulkadir

    (Mercury Publication)

Abstract

We examine the responsiveness of pharmaceutical companies’ R&D strategies to the length of_x000D_ the regulatory delay. This delay is caused by U.S. Federal Drug Administration (FDA) policies in_x000D_ place regarding testing of newly developed drugs. We extend our p

Suggested Citation

  • Chorniy, Anna & Bailey, James & Maloney, Michael & Civan, Abdulkadir, 2019. "Regulatory Review Time and Pharmaceutical R&D," Working Papers 06923, George Mason University, Mercatus Center.
    • Handle: RePEc:ajw:wpaper:06923
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    References listed on IDEAS

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    1. Mary K. Olson, 2002. "Pharmaceutical Policy Change and the Safety of New Drugs," Journal of Law and Economics, University of Chicago Press, vol. 45(S2), pages 615-642.
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    3. Philipson, Tomas & Berndt, Ernst R. & Gottschalk, Adrian H.B. & Sun, Eric, 2008. "Cost-benefit analysis of the FDA: The case of the prescription drug user fee acts," Journal of Public Economics, Elsevier, vol. 92(5-6), pages 1306-1325, June.
    4. Vernon, John A. & Golec, Joseph H. & Lutter, Randall & Nardinelli, Clark, 2009. "An exploratory study of FDA new drug review times, prescription drug user fee acts, and R&D spending," The Quarterly Review of Economics and Finance, Elsevier, vol. 49(4), pages 1260-1274, November.
    5. Blume-Kohout, Margaret E. & Sood, Neeraj, 2013. "Market size and innovation: Effects of Medicare Part D on pharmaceutical research and development," Journal of Public Economics, Elsevier, vol. 97(C), pages 327-336.
    6. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G., 2003. "The price of innovation: new estimates of drug development costs," Journal of Health Economics, Elsevier, vol. 22(2), pages 151-185, March.
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