Which federal entity is primarily responsible for drug testing oversight before clinical trials in humans?

• A. NIH
• B. FDA
• C. CDC
• D. EPA

Answer: (B)

The key idea is that the FDA oversees the safety and regulatory approval process for testing new drugs in humans. Before any clinical trials can start, a sponsor must submit an investigational new drug application that includes extensive preclinical data, explanations of how the drug is manufactured, and a plan for human studies. The FDA reviews this information to decide whether it’s reasonable to begin testing in people and to ensure participant safety. If the FDA is satisfied, trials can move forward under controlled conditions and with compliance to quality standards.

Other agencies have related, but different, roles: NIH mostly funds research, CDC focuses on public health and disease control, and the EPA regulates environmental and chemical safety.