IND stands for?

• A. Investigational New Drug Application
• B. International New Drug
• C. Independent Drug
• D. Investigational Non-Drug

Answer: (A)

In the regulatory context, the main idea tested is identifying the formal term used for starting human testing of a new drug. IND stands for Investigational New Drug Application. In the United States, sponsors must submit an IND to the FDA before any new chemical or biological entity can be studied in people. This submission includes preclinical safety data, details about how the drug is manufactured to ensure quality, and the plan for proposed human trials (protocols and investigator qualifications). Submitting the IND gives FDA the opportunity to review safety before first-in-human studies and, once approved, allows the drug to be shipped across state lines for the trial. The other options don’t reflect the established regulatory terminology: there isn’t a global “International New Drug” process, nor a concept of an “Independent Drug,” and an “Investigational Non-Drug” would mischaracterize the purpose of the submission, which is specifically tied to a potential new drug.