drug approval

drug approval

The formal process through which drugs are tested before they are permitted to be sold. In the U.S., the process involves a series of studies on small groups of patients affected by diseases for which the drug may prove beneficial. These trials include: 1. studies of the drug's safety; 2. studies of the drug's efficacy; 3. studies of the drug's comparative efficacy relative to other agents that treat the same or similar problems.