Abstract
Policy research examines, among other things, factors related to the development and review of new drugs, allowing one to assess the overall outcome of the processes involved therein. Results of this research may directly influence development strategies. For example, data on relative development times of drugs in different therapeutic classes may constitute incentives for pursuing drug development in some therapeutic areas and disincentives in others. As another example, data on the average length of time required for approval of second or further indications for already approved drugs may dissuade a sponsor from initiating supplemental indication research, especially when taken in conjunction with the deterioration of patent protection time and the growth of generic prescribing. These and other policy data related to the drug development and review processes are presented, and their impact on development strategies is discussed.
Get full access to this article
View all access options for this article.