The need for speed and safety: A primer on the FDA's drug approval pathwaysPublished: May 2022 At the heart of the Food and Drug Administrations work on drugs are some deceptively simple questions: Does the medicine in question provide a benefit for patients that outweighs its risks? Will the medicine at least keep the disease from progressing? Can doctors and patients believe the FDA has made the right call in approving this drug? The FDA's traditional approval process involves a series of rigorous clinical trials that can