What submission is required before beginning human testing of a new drug?

• A. Investigational New Drug (IND) application
• B. New Drug Application
• C. Abbreviated New Drug Application
• D. Biologics License Application

Answer: (A)

Before any new drug can be tested in people, regulators require a formal submission called the Investigational New Drug application. This lets the FDA review the preclinical safety data, how the drug is manufactured, and the plan for initial human trials. It also includes information about who will run the studies and how participants will be protected through informed consent and ethical review. The FDA uses this review to identify safety concerns before humans are exposed to the drug and may request additional data or place a hold if issues arise.

After successful early testing, a New Drug Application would be submitted to seek approval to market the drug. An Abbreviated New Drug Application is for generic versions of an existing drug, not a new one. A Biologics License Application is the equivalent path for biologic products, rather than small-molecule drugs. The submission described here is the one that authorizes beginning human trials.