How Does The FDA Decide Whether A Drug Is Safe And Effective?

By Richard F. Lockey | Tampa Tribune | June 14, 2008

Dr. Lockey, a professor at the University of South Florida, explains the Food and Drug Administration’s (FDA) drug approval process, focusing particularly on the allergy drug Singulair. This 1993 OTA report on pharmaceutical research and development describes the length of time involved and success rate of drug development in the U.S.