How To Enhance Efficiencies In Clinical Development And Market Approval

By David Shoemaker, Senior Vice President Research and Development, Rho

Once a sponsor has completed research and clinical trials and believes enough evidence is available on the safety and effectiveness of the new drug, the final step of the development process is to submit an application to regulatory authorities to gain approval for marketing the product. The application must contain data outlining the technical specifications of the product, as well as statistical analyses demonstrating the safety and efficacy of the new molecular entity as evidence of the acceptable benefit:risk profile.