Which agency requires animal testing for drugs before human testing?

• A. NIH
• B. FDA
• C. EPA
• D. CDC

Answer: (B)

Before a new drug can be tested in people, safety data from animal studies are needed to predict potential risks in humans and to establish a starting dose for first-in-human trials. In the United States, the agency that requires this preclinical animal testing for drugs is the FDA, which reviews animal pharmacology and toxicology data as part of an Investigational New Drug application before human testing can begin. NIH mainly funds biomedical research and does not regulate the drug approval process; EPA deals with environmental chemicals and pesticides (not the standard drug development pathway for pharmaceuticals); CDC focuses on public health and disease control. So the FDA is the one that requires animal testing before moving on to human trials.