Ann C. Tunstall talks about the Food and Drug Administration (FDA), how it began and how its attributions have been changing through time. She explains how drugs and medical devices are approved by this institution and comments on the three phases for clinical testing on drugs: safety and toxicity; safety, proof of concept and dose selection; and safety and efficacy. She also shares the differences between the United States and the European regulation for medicine and the critics the FDA regulary receive for its strict laws of approval.