Which agency requires laboratory animal testing for drugs before testing in humans?

• A. FDA (Food and Drug Administration)
• B. EPA (Environmental Protection Agency)
• C. NIH (National Institutes of Health)
• D. CDC (Center for Disease Control)

Answer: (A)

Animal testing is done in drug development to evaluate safety, toxicology, and pharmacokinetics before humans are exposed to a new medicine. The agency that requires this step is the FDA. The FDA’s regulatory process mandates preclinical data from well-conducted animal studies under Good Laboratory Practice, and these results are used to determine a safe starting dose and assess risks for first-in-human trials through an Investigational New Drug application. The EPA handles environmental and chemical safety, NIH is a funding body for research, and the CDC focuses on public health; none of them gate the initiation of human trials in the way the FDA does.