Which regulatory body requires laboratory animal testing before human drug trials?

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

Answer: (A)

Safety testing in animals before human studies is a standard regulatory step in drug development to assess toxicity, pharmacology, and overall safety. In the United States, this preclinical data is reviewed by the agency responsible for approving new drugs for human testing, which requires an Investigational New Drug submission containing animal study results and other safety data. The goal is to ensure that volunteers are not exposed to undue risk. The other organizations have different roles: the EPA governs environmental safety and may require animal testing for certain chemicals or pesticides, but not the routine approval of human drug trials; the NIH funds and conducts research but does not authorize clinical trials; the CDC focuses on public health and disease control rather than approving drug testing in humans.