Now showing items 1-10 of 10

    • 5-α reductase inhibitors and prostate cancer prevention: where do we turn now? 

      Hamilton, RJ; Freedland, SJ (BMC Med, 2011-09-15)
      With the lifetime risk of being diagnosed with prostate cancer so great, an effective chemopreventive agent could have a profound impact on the lives of men. Despite decades of searching for such an agent, physicians still ...
    • Developing drugs for developing countries. 

      Grabowski, Henry G; Moe, Jeffrey L; Ridley, David Blaine (Health Aff (Millwood), 2006-03)
      Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments ...
    • Economic return of clinical trials performed under the pediatric exclusivity program. 

      Benjamin, Daniel Kelly; Califf, Robert M; Eisenstein, EL; Goldsmith, JV; Grabowski, Henry G; Li, JS; Mangum, B; ... (10 authors) (JAMA, 2007-02-07)
      CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
    • Economics of new oncology drug development. 

      DiMasi, Joseph A; Grabowski, Henry G (J Clin Oncol, 2007-01-10)
      PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company ...
    • Priorities for the Priority Review Voucher. 

      Ridley, David Blaine (Am J Trop Med Hyg, 2017-01-11)
      The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease ...
    • Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. 

      Grabowski, Henry G; Guha, R; Salgado, M (Health Aff (Millwood), 2014-06)
      In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing ...
    • Spending on postapproval drug safety. 

      Grabowski, Henry G; Kramer, JM; Ridley, David Blaine; Schulman, Kevin Alan; Tilson, HH (Health Aff (Millwood), 2006-03)
      Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding ...
    • Strategic use of statistical thinking in drug development. 

      Rockhold, Frank Wesley (Stat Med, 2000-12-15)
      The role of the statistician and statistical thinking in the pharmaceutical industry has evolved greatly in the last four or five decades. Regulatory developments and the changing face of the science of drug development ...
    • The price of innovation: new estimates of drug development costs. 

      DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W (J Health Econ, 2003-03)
      The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of ...
    • The roles of patents and research and development incentives in biopharmaceutical innovation. 

      DiMasi, Joseph A; Grabowski, Henry G; Long, Genia (Health Aff (Millwood), 2015-02)
      Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms ...