GAO: Issues Cited as Hampering Drug Development (Nov. 17, 2006)
Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts (Nov. 17, 2006)
The GAO analyzed data from the FDA on all 1,264 New Drug Applications submitted to the agency from 1993 through 2004. GAO also convened a panel of experts and interviewed other drug development experts and analysts to identify factors affecting, and suggestions for enhancing, drug development. Although the pharmaceutical industry reported substantial increases in annual research and development costs, the number of NDAs submitted to, and approved by, FDA has not been commensurate with these investments.