ABSTRACT
An investigational new drug is a pharmaceutical product for which effectiveness and safety in humans have not yet been demonstrated. A licensed drug used for investigational purposes in a manner that varies from the approved indication would likewise be considered an investigational new drug. In the United States, the Food and Drug Administration (FDA) helps to ensure that products approved for commercial use are pure, potent, safe, and effective. The regulatory process affects drug development at the preclinical, clinical, license application, and post-licensure stages. This chapter primarily describes the role of the FDA during the clinical and license application stages. In the United States, before a clinical research study can be initiated, a sponsor submits an investigational new drug (IND) application to the FDA for review and approval.
