What is the term for the FDA regulatory process that initiates testing of a new drug in humans?

• A. Investigational New Drug (IND)
• B. New Drug Application (NDA)
• C. Placebo
• D. Double-Blind Study

Answer: (A)

The term for the FDA regulatory step that starts testing a new drug in humans is the Investigational New Drug designation. Before testing in people, preclinical studies in the lab and in animals provide data on safety, pharmacology, and toxicology. An IND submission to the FDA compiles this preclinical data, details about how the drug is manufactured, and the plan for the initial human trials. The FDA reviews the IND and, if there are no safety objections, allows the sponsor to begin clinical testing in humans (Phase 1) under an approved protocol. If safety concerns arise, the FDA can place a hold on further testing.

New Drug Application is the later step to seek permission to market the drug after successful clinical trials. A placebo is an inactive substance used as a control, and a double-blind study is a design where neither participants nor investigators know who receives the drug versus placebo to reduce bias.