Regulations imposed by the U.S. government by the FDA are a significant factor in the conduct of the research, development, manufacturing, and eventual marketing activities for Pro-Pharmaceuticals' proposed products. The regulatory process for the development and approval of a new drug includes the conduct of pre-clinical trials, clinical trials and pre-market approval.

The duration of those trials and number of subjects required to meet the requirements of the FDA vary according to several factors. They include, the disease studied, the seriousness of the side effects, whether there is any current or conventional therapy, the size of the target population, the nature of the proposed treatment, as well as other factors.