What is the purpose of the Investigational New Drug Application (INDA)?

The purpose of the Investigational New Drug Application (INDA) is to seek authorization from the Food and Drug Administration (FDA) to begin testing a new drug on humans. This application is a crucial step in the drug development process, as it provides the necessary information about the drug’s composition, manufacturing, and proposed clinical trial protocols to ensure safety and efficacy before human trials can commence. Through the INDA, the FDA evaluates whether the proposed studies adequately protect the rights and welfare of participants while also ensuring that the scientific objectives of the research are sound.

The focus is specifically on the clinical trials involving human subjects, which are integral to demonstrating that a drug is safe and effective for the intended use. Other options, while related to drug management and safety, do not align with the primary function of the INDA. For instance, the INDA does not pertain to the approval of over-the-counter drugs, nor does it classify prescription drugs or address the prevention of poisonings independently. Therefore, the correct answer highlights the essential role of the INDA in facilitating clinical trials to evaluate new drug therapies in human populations.