Which statement best describes the use of an IND?

• A. To license a device
• B. To distribute across state lines before FDA review
• C. To approve a generic product
• D. To register a device

Answer: (B)

The main idea being tested is how an IND functions to enable clinical testing in humans. An IND (Investigational New Drug application) is the mechanism that lets a sponsor ship an investigational drug across state lines to clinical trial sites, so researchers can study its safety and effects in people under FDA oversight. The IND must be in effect before such testing proceeds, which means the FDA has reviewed the application and not issued a clinical hold, with a typical 30-day waiting period after receipt unless issues arise. This is distinct from licensing a device, approving a generic product, or registering a device. The purpose is specifically to authorize and regulate the conduct of human trials of an investigational drug before any marketing approval.