What is involved in approving a medicine?
All medicines have benefits as well as risks. Before any new medicine is approved by regulatory agencies , it undergoes extensive testing—usually in several thousand people. The goal of this testing is to determine how safe and effective the medicine is—and to show that its benefits outweigh the known risks. A medicine is approved for use by appropriate patients only when its benefits have been adequately shown to outweigh the risks for its intended use in those patients.
